Devices

Device Recall Infinia

  • Model / Serial
    Serial Numbers for all devices: 22, 343, 1002, 1003, 1006, 1007, 1008, 1010, 1012, 1013, 1016, 1018, 1019, 1021, 1025, 1026, 1027, 1034, 1035, 1038, 1039, 1042, 1043, 1046, 1056, 1058, 1060, 1061, 1065, 1066, 1069, 1072, 1073, 1074, 1075, 1076, 1078, 1080, 1081, 1085, 1086, 1091, 1095, 1099, 1100, 1101, 1101, 1102, 1105, 1106, 1107, 1110, 1111, 1112, 1116, 1118, 1119, 1126, 1132, 1141, 1144, 1145, 1149, 1153, 1155, 1289, 1372, 1505, 1538, 1617, 1629, 1649, 1666, 1693, 1696, 1697, 1704, 1729, 1730, 1756, 1804, 1814, 1831, 1835, 1890, 1998, 1999, 3003, 5004, 5007, 8007, 10023, 10028, 10032, 10040, 10041, 10057, 10103, 10115, 10121, 10124, 10129, 10130, 10133, 10138, 10139, 10143, 10146, 10146, 10150, 10156, 10158, 10164, 10165, 10166, 10167, 10168, 10169, 10171, 10172, 10173, 10175, 10176, 10177, 10178, 10179, 10180, 10180, 10182, 10185, 10187, 10188, 10189, 10190, 10191, 10193, 10194, 10195, 10197, 10199, 10204, 10206, 10207, 10209, 10210, 10211, 10212, 10216, 10217, 10218, 10222, 10224, 10225, 10228, 10229, 10230, 10234, 10235, 10236, 10237, 10238, 10239, 10240, 10241, 10242, 10243, 10244, 10246, 10249, 10250, 10251, 10253, 10254, 10256, 10260, 10262, 10263, 10264, 10265, 10267, 10268, 10269, 10270, 10272, 10276, 10279, 10280, 10281, 10282, 10283, 10284, 10287, 10288, 10292, 10294, 10295, 10297, 10298, 10300, 10302, 10303, 10305, 10307, 10308, 10309, 10311, 10312, 10313, 10314, 10316, 10319, 10320, 10323, 10325, 10326, 10328, 10332, 10333, 10334, 10335, 10336, 10336, 10337, 10338, 10339, 10340, 10342, 10343, 10345, 10346, 10347, 10348, 10352, 10353, 10354, 10355, 10357, 10359, 10360, 10362, 10363, 10364, 10366, 10367, 10368, 10370, 10371, 10373, 10374, 10375, 10376, 10377, 10378, 10379, 10381, 10382, 10383, 10384, 10385, 10386, 10387, 10388, 10389, 10390, 10392, 10393, 10395, 10396, 10397, 10398, 10399, 10400, 10401, 10401, 10402, 10403, 10405, 10406, 10407, 10408, 10409, 10410, 10411, 10412, 10413, 10414, 10416, 10417, 10420, 10422, 10424, 10425, 10426, 10428, 10431, 10434, 10435, 10436, 10437, 10438, 10439, 10445, 10446, 10447, 10448, 10449, 10450, 10453, 10454, 10456, 10457, 10458, 10459, 10460, 10461, 10462, 10463, 10466, 10467, 10468, 10470, 10473, 10474, 10475, 10476, 10477, 10479, 10480, 10481, 10483, 10485, 10486, 10487, 10488, 10489, 10491, 10493, 10494, 10495, 10498, 10501, 10504, 10505, 10507, 10508, 10510, 10511, 10512, 10514, 10516, 10518, 10519, 10520, 10521, 10522, 10525, 10526, 10527, 10529, 10530, 10531, 10532, 10533, 10534, 10537, 10538, 10539, 10540, 10541, 10542, 10543, 10544, 10545, 10547, 10548, 10548, 10550, 10551, 10552, 10553, 10555, 10556, 10557, 10558, 10559, 10560, 10561, 10562, 10563, 10564, 10565, 10568, 10571, 10572, 10573, 10574, 10575, 10576, 10578, 10579, 10581, 10582, 10584, 10585, 10586, 10587, 10589, 10590, 10591, 10592, 10593, 10594, 10595, 10596, 10597, 10598, 10599, 10600, 10601, 10603, 10605, 10606, 14119, 14258, 14286, 14335, 15004, 15006, 15009, 15010, 15011, 15012, 15013, 16001, 16002, 16004, 16005, 16006, 16007, 16008, 16009, 16010, 16010, 16013, 16014, 16015, 16016, 16017, 16018, 16019, 16020, 16021, 16022, 16023, 16024, 16026, 16027, 16028, 16029, 16030, 16033, 16035, 16036, 16037, 16038, 16039, 16040, 16041, 16043, 16044, 16045, 16046, 16048, 16049, 16050, 16051, 16052, 16053, 16054, 16055, 16056, 16057, 16058, 16059, 16060, 16061, 16062, 16063, 16065, 16066, 16067, 16068, 16069, 16070, 16071, 16072, 16073, 16074, 16075, 16076, 16078, 16079, 16081, 16082, 16083, 16084, 16085, 16086, 16088, 16089, 16090, 16092, 16093, 16094, 16095, 16096, 16097, 16098, 16099, 16101, 16103, 16104, 16106, 16107, 16108, 16109, 16110, 16111, 16112, 16113, 16114, 16115, 16116, 16118, 16119, 16120, 16121, 16122, 16123, 16124, 16125, 16126, 16127, 16128, 16129, 16130, 16131, 16132, 16133, 16134, 16135, 16136, 16137, 16138, 16139, 16140, 16141, 16142, 16143, 16145, 16146, 16148, 16149, 16151, 16152, 16153, 16154, 16155, 16156, 16157, 16158, 16159, 16160, 16162, 16163, 16164, 16166, 16168, 16169, 16170, 16171, 16171, 16172, 16173, 16174, 16175, 16176, 16177, 16178, 16179, 16180, 16182, 16183, 16184, 16185, 16186, 16188, 16189, 16190, 16191, 16192, 16193, 16194, 16195, 16196, 16197, 16198, 16199, 16200, 16201, 16202, 16203, 16204, 16205, 16207, 16208, 16209, 16210, 16211, 16212, 16213, 16214, 16215, 16216, 16217, 16218, 16219, 16220, 16221, 16222, 16223, 16224, 16225, 16227, 16228, 16229, 16231, 16232, 16233, 16234, 16235, 16236, 16237, 16238, 16239, 16239, 16240, 16241, 16242, 16243, 16244, 16245, 16246, 16248, 16249, 16250, 16251, 16252, 16253, 16254, 16255, 16256, 16258, 16259, 16260, 16261, 16262, 16263, 16264, 16265, 16266, 16267, 16268, 16269, 16270, 16271, 16272, 16273, 16274, 16275, 16276, 16277, 16278, 16279, 16280, 16281, 16282, 16283, 16284, 16285, 16286, 16287, 16288, 16289, 16290, 16292, 16293, 16294, 16295, 16296, 16297, 16298, 16299, 16300, 16301, 16302, 16303, 16304, 16305, 16306, 16307, 16308, 16309, 16310, 16311, 16312, 16313, 16315, 16316, 16317, 16318, 16319, 16320, 16321, 16322, 16323, 16324, 16325, 16326, 16327, 16329, 16330, 16331, 16332, 16333, 16334, 16335, 16336, 16337, 16338, 16339, 16340, 16341, 16342, 16343, 16344, 16345, 16346, 16347, 16348, 16349, 16350, 16352, 16353, 16354, 16355, 16356, 16357, 16358, 16359, 16360, 16361, 16362, 16363, 16364, 16366, 16367, 16368, 16369, 16370, 16371, 16372, 16374, 16375, 16376, 16377, 16378, 16379, 16380, 16381, 16382, 16383, 16384, 16385, 16386, 16387, 16388, 16389, 16390, 16392, 16393, 16394, 16395, 16396, 16397, 16398, 16399, 16400, 16401, 16402, 16403, 16404, 16405, 16406, 16407, 16408, 16409, 16410, 16411, 16412, 16413, 16414, 16415, 16416, 16417, 16418, 16419, 16420, 16421, 16422, 16423, 16424, 16425, 16426, 16427, 16428, 16429, 16429, 16430, 16431, 16432, 16433, 16434, 16435, 16436, 16437, 16438, 16439, 16440, 16441, 16442, 16443, 16444, 16445, 16446, 16447, 16448, 16449, 16450, 16451, 16452, 16453, 16454, 16455, 16456, 16457, 16458, 16459, 16460, 16461, 16462, 16463, 16464, 16465, 16466, 16467, 16468, 16469, 16470, 16471, 16474, 16475, 16475, 16476, 16477, 16478, 16479, 16480, 16481, 16482, 16483, 16484, 16485, 16486, 16487, 16488, 16489, 16490, 16491, 16493, 16494, 16495, 16496, 16497, 16498, 16499, 16500, 16501, 16502, 16503, 16504, 16505, 16506, 16507, 16508, 16509, 16510, 16511, 16512, 16513, 16514, 16515, 16515, 16516, 16517, 16518, 16519, 16520, 16521, 16522, 16523, 16524, 16525, 16526, 16527, 16528, 16529, 16530, 16531, 16532, 16533, 16534, 16535, 16536, 16537, 16538, 16539, 16540, 16541, 16542, 16543, 16544, 16545, 16546, 16547, 16548, 16549, 16550, 16551, 16552, 16553, 16554, 16555, 16556, 16557, 16558, 16559, 16560, 16561, 16562, 16563, 16564, 16565, 16566, 16567, 16569, 16570, 16571, 16572, 16573, 16574, 16575, 16576, 16577, 16578, 16579, 16580, 16581, 16582, 16583, 16584, 16585, 16586, 16587, 16588, 16589, 16590, 16591, 16592, 16593, 16594, 16595, 16596, 16597, 16598, 16599, 16601, 16602, 16604, 16605, 16606, 16607, 16608, 16609, 16610, 16611, 16612, 16613, 16614, 16615, 16616, 16617, 16618, 16619, 16620, 16621, 16622, 16623, 16624, 16625, 16626, 16627, 16628, 16629, 16630, 16631, 16632, 16633, 16634, 16635, 16636, 16637, 16638, 16639, 16640, 16641, 16642, 16643, 16644, 16645, 16646, 16647, 16648, 16649, 16651, 16652, 16653, 16654, 16655, 16656, 16657, 16658, 16659, 16660, 16661, 16662, 16663, 16664, 16665, 16666, 16667, 16668, 16669, 16670, 16671, 16672, 16673, 16674, 16675, 16676, 16678, 16679, 16680, 16681, 16682, 16683, 16684, 16685, 16686, 16687, 16688, 16689, 16690, 16691, 16692, 16693, 16694, 16695, 16696, 16697, 16698, 16699, 16700, 16701, 16702, 16703, 16704, 16705, 16706, 16707, 16708, 16709, 16710, 16711, 16712, 16713, 16714, 16715, 16716, 16717, 16718, 16719, 16720, 16721, 16723, 16724, 16725, 16726, 16727, 16728, 16729, 16730, 16731, 16732, 16733, 16734, 16735, 16736, 16737, 16738, 16739, 16740, 16741, 16742, 16743, 16744, 16745, 16746, 16747, 16748, 16749, 16750, 16751, 16752, 16753, 16754, 16755, 16756, 16757, 16758, 16759, 16760, 16761, 16762, 16764, 16765, 16766, 16767, 16768, 16769, 16770, 16771, 16772, 16773, 16774, 16775, 16776, 16777, 16778, 16779, 16780, 16781, 16782, 16783, 16784, 16785, 16786, 16787, 16788, 16789, 16790, 16791, 16792, 16793, 16794, 16795, 16796, 16797, 16798, 16799, 16800, 16801, 16802, 16802, 16803, 16804, 16805, 16806, 16807, 16808, 16809, 16810, 16811, 16812, 16813, 16815, 16816, 16817, 16818, 16819, 16820, 16821, 16822, 16823, 16824, 16825, 16826, 16827, 16828, 16829, 16830, 16831, 16832, 16833, 16834, 16835, 16836, 16837, 16838, 16839, 16840, 16841, 16842, 16843, 16844, 16845, 16846, 16848, 16849, 16850, 16851, 16851, 16852, 16853, 16854, 16855, 16856, 16857, 16858, 16859, 16860, 16861, 16862, 16863, 16864, 16865, 16866, 16867, 16868, 16869, 16870, 16871, 16872, 16873, 16874, 16875, 16877, 16878, 16879, 16880, 16881, 16882, 16883, 16884, 16885, 16886, 16887, 16888, 16889, 16891, 16892, 16893, 16894, 16895, 16896, 16897, 16898, 16899, 16900, 16901, 16902, 16903, 16904, 16905, 16906, 16907, 16908, 16909, 16910, 16911, 16912, 16913, 16914, 16915, 16916, 16917, 16918, 16919, 16920, 16921, 16922, 16923, 16924, 16925, 16926, 16927, 16928, 16929, 16930, 16931, 16932, 16933, 16934, 16935, 16936, 16937, 16938, 16939, 16940, 16941, 16942, 16943, 16944, 16945, 16946, 16947, 16948, 16949, 16950, 16951, 16952, 16953, 16954, 16955, 16956, 16957, 16958, 16959, 16960, 16961, 16962, 16963, 16964, 16965, 16966, 16967, 16968, 16969, 16970, 16971, 16972, 16973, 16974, 16975, 16976, 16977, 16979, 16980, 16981, 16982, 16983, 16984, 16985, 16986, 16987, 16988, 16989, 16990, 16991, 16992, 16993, 16994, 16995, 16996, 16997, 16998, 17000, 17001, 17002, 17003, 17004, 17005, 17006, 17007, 17008, 17009, 17010, 17011, 17012, 17013, 17014, 17015, 17016, 17017, 17018, 17019, 17020, 17021, 17022, 17023, 17024, 17025, 17026, 17027, 17028, 17029, 17030, 17031, 17032, 17034, 17035, 17036, 17037, 17038, 17039, 17040, 17041, 17042, 17043, 17045, 17046, 17047, 17048, 17049, 17050, 17051, 17052, 17053, 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000003100-1829, 000003100-1838, 000003100-1840, 000003101-1502, 000003651-4185, 000003681-1803, 000003818-1210, 000003818-1224, 000003818-4187, 000008125-1630, 00000I92S08001, 00000ICPO50612, 00003618-12-26, 00003652-41-95, 00003817-11-12, 00003817-11-69, 00003818-11-41, 00003818-11-47, 00003818-11-82, 00003818-12-19, 00003818-32-02, 00008125-16-25, 00008125-16-70, 00008125-16-88, 00008125-16-89, 00008125-18-09, 00008125-18-10, 00008125-18-16, 00008125-18-18, 0000D4360X4372, 0003811-81-231, DUMFMI40849005, DUMFMI40849009, DUMFMI40849010, DUMFMI40849011, DUMFMI40849012, DUMFMI40849013, DUMFMI40849014, DUMFMI40849015, DUMFMI40849016, DUMFMI40849017, DUMFMI40849018, DUMFMI40849019, DUMFMI40849020, DUMFMI40849023, DUMFMI40849026, UNKASM00109200, UNKASM00109201, UNKASM00109204, UNKELS00000372.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and Guam and the countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, and United Kingdom.
  • Product Description
    GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
  • Manufacturer
    GE Healthcare, LLC
  • 1 Event

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Infinia
  • Model / Serial
    System ID: 1153389, 1299296, 2555007, 2621801, 2638808, 2694593, 2760723, 2768147, 2769200, 2775945, 2812777, 2827087, 2883051, 0828260003, 0828260005, 0828260006, 0828260007, 0828260009, 0828260011, 0828260013, 0828260015, 0828260017, 0828260018, 0828260019, 0828260020, 0834260003, 0834260008, 0834260012, 835260007, 0835260010, 0835260013, 0843260029, 0843260032, 0843260034, 0843260037, 0843260044, 0843260047, 0843260048, 0847260025, 0850260060, 0850260061, 0850260063, 0850260064, 0850260065, 0850260066, 0850260067, 0850260068, 0850260069, 0850260070, 0850260073, 0850260074, 0850260075, 0850260076, 0850260077, 0850260079, 0850260080, 0850260081, 0850260082, 0850260083, 0850260084, 0850260087, 0850260088, 0850260089, 0850260090, 0850260091, 0850260092, 0850260093, 0850260094, 0850260095, 0850260096, 0850260098, 0850260099, 0850260100, 0850260103, 0850260104, 0850260105, 0850260106, 0850260107, 0850260108, 0850260109, 0850260110, 0850260111, 0850260112, 0850260113, 0850260114, 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083026862101014, 083026867892981, 083026867892988, 00002NUC02, 00013NUC01, 00018NUC04, 00034NUC01, 00053NUC06, 00053NUC09, 00065NUC05, 00067NUC01, 00100NUC02, 00105NUC03, 00109NUC01, 00109NUC04, 00116NUC01, 00130NUC03, 00130NUC04, 00131NUC03, 00133NUC21, 00136NUC03, 00136NUC08, 00141NUC06, 00165NUC04, 00169NUC07, 00171NUC04, 00186NUC02, 00187NUC01, 00197NUC11, 00203NUC03, 00216NUC11, 00231NUC09, 00234NUC05, 00240NUC05, 00253NUC02, 00257NUC06, 00257NUC15, 00260NUC03, 00263NUC08, 00271NUC04, 00289NUC02, 00311NUC01, 00313NUC01, 00318NUC03, 00318NUC10, 00331NUC02, 00348NUC02, 00361NUC05, 00371NUC04, 00373NUC01, 00374NUC05, 00379NUC01, 00383NUC03, 00393NUC06, 00433NUC09, 00439NUC08, 00440NUC07, 00440NUC09, 00440NUC11, 00487NUC04, 00669NUC01, 01002NUC04, 010120NU11, 01012NUC01, 01042NUC01, 01243NUC02, 01344NUC01, 01367NUC01, 030010NU05, 030018NU05, 030037NU04, 030057NU05, 030078NU13, 030151NU12, 030209NU02, 030232NU10, 030232NU13, 030240NU07, 030388NU04, 030419NU09, 05217NUC05, 05452NUC03, 06008NUC09, 06014NUC02, 06051NUC01, 06051NUC04, 06109NUC01, 06109NUC02, 07015NUC01, 080004NU11, 080004NU13, 080026NU08, 080053NU02, 100029NU01, 10181NUC06, 10448NUC04, 10497NUC01, 10497NUC03, 10627NUC01, 110009NU01, 110022NU03, 110034NU04, 110064NU01, 110093NU07, 11018NUC04, 130083NU13, 130139NU02, 150017NU05, 1577INFINIA, 160150NU04, 17005NUC01, 18076INFINIA, 190052NU06, 190057NU05, 190057NU10, 190073NU01, 190171NU05, 190187NU01, 190194NU01, 190205NU06, 190282NU09, 202715INF4, 203325INF, 203325INF2, 203384INF, 203688INF, 203797INF, 203852INF, 204787INFINIA, 204787INFINIA2, 204837HK1, 204837IN1, 205408INF2, 205750INF, 205759INF, 205783INF1, 205939INF, 206223INF, 206223INF2, 207255INFINIA, 207795INFINIA, 208422INF, 209223IN, 209385IN, 209526IN, 209831IN, 210036NU06, 21011NUC01, 210358IHE, 210575INF1, 210617NM1, 210705NM1, 210757NM1, 210921NM1, 210MTINFINIA, 212241INF1, 212241INF2, 212241INF3, 212562INF1, 212608INF1, 212686INF1, 212989INF1, 214324INF, 214370INF, 214820INF1, 214820INF2, 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A5181662, A5189714, A5197927, A5197934, A5198016, A5215935, A5216823, A5216824, A5224207, A5267107, A5279301, A5279302, A5306502, A5315551, A5352208, A5367805, A5547414, A5634003, A5649008, A5719812, A58080111, A58080134, A5924402, A99263311, AC001NU14, AC001NU18, AF1026NM01, AH1908NU01, AH1908NU02, AH3403NU01, AH3701NM05, AH4307NM05, AH4660NM06, AH5117NU02, AH5249NM04, AH5293NM04, AH5689NU01, AH5689NU03, AH5689NU04, AH5844NM05, ALM0131, AMS0338, APL0232, ARHINFI, B1650218, B1768001, B4155415, B4182004, B5119121, B5142302, B5142304, B5174320, B5315345, B5357630, B5365422, B5395703, B5483443, B5618331, BCHINF1, BRMCINF, C001NU06, C001NU10, C4191749, C4191765, C5120912, C5120915, CC3899NU01, CE561221, CFRHINF, CHAM01NU01, COR359309, COR369576, COR373273, COR373282, CRAVENINF1, CRAVENINF2, CRAVENINF3, CS1008NM03, CS1021NM03, CS1052NM08, CS1052NM09, CS1277NM01, CS1277NM02, CS1318NM01, CSNMINFINIA, CY1015NM01, D5111602, D5111607, DE492A51, DE528467, DE539254, DE6588112, DEH13556, DEN01721, DEN01723, DEN01725, DEN01727, DHG0539, DK1022NM05, DK1023NM03, DK1023NM05, DK1026NM07, DK1026NM08, DK1029NM05, DK1065NM04, DK1065NM05, DPN00002, DVT0138, DZ1035NM03, DZ1035NM04, DZ1147NM01, DZ1279NM01, DZ1338NM01, E001NU16, E4858901, EE1019NM02, EE238526, EEF51540, EG1100MN01, EG1124MN02, EG1538MN01, EG1826MN01, EMM0131, F5119151, FE443890, FEB33835, FEE12426, FEG46134, FHEINF, FI1000MN04, FI1003MN05, FI1003MN06, FI1010NM01, FI1019MN01, FI1021MN01, FI1023MN02, FI1029MN01, FI1064MN01, FI1153MN01, FPG86405, G4191710, GE1004NM01, GILESINF, GOLD001642, GOLD010343, GOU0137, GOU0138, GPQ19105, H002NU01, H010NU04, H010NU08, H2094NUC07, H2094NUC28, H2100NUC02, H2193NUC13, H4858974, HC0074NU01, HC0507NU03, HC0842NU01, HC0863NU01, HC0892NU04, HC1249NU01, HC1249NU02, HC1819NU01, HC2252NU01, HC2720NU02, HC3442NU01, HC4387NU02, HC4480NU01, HC7475NU03, HDB0130, HGL0233, HGV0130, HLUE01NU01, HLV0334, HR4103NM01, HU1039NM02, HU1099NM01, IE1006MN04, IE1029MN04, IE1029MN05, IE1053MN01, IE1085MN05, IE1100MN01, IE1110MN01, IE1510MN09, IE1510MN12, IE1510MN16, IE1564NM01, IE1564NM03, IL1018NM07, IL1018NM08, IL1020NM25, IL1020NM31, IL1028NM26, IL1041NM18, IL1041NM22, IL1041NM28, IL1041NM29, IL1042NM09, IL1043NM20, IL1059NM07, IL1062NM26, IL1068NM05, IL1069NM06, IL1069NM11, IL1331NM01, INF2649553, IR1049NM01, IR1501NM01, JO1034NM01, JOHNINF, KW1001MN23, KW1001MN25, KW1005MN11, KW1005MN14, KW1006NM01, KW1013NM01, KW1013NM02, KW1018MN05, KW1018MN06, KW1018MN08, LB1122NM02, LDD0431, LDD0433, LGMCINF, LGMCINF2, LT4000MN01, LT4000MN02, LV4002NM02, M1106608, M1279727, M1400803, M1804913, M1804914, M204493801, M2147255, M218669001, M2269829, M23084315, M256517203, M2645705, M2846905, M4018099, M4018536, M4023087, M4024095, M40345193, M4040544, M4111216, M4135141, M4135145, M4143953, M4144332, M4144340, M4145143, M4159227, M4159228, M4159235, M4159460, M4160449, M4163763, M4167153, M4184856, M4191430, M4194031, M4198189, M4215553, M4234232, M4234235, M4479619, M4480229, M4480232, M44827146, M4496943, M5172527, M54606103, M7411101, M7411106, M8572211, M9162716, M9164758, M9319116, M9886832, MA1020NM01, MA1272NM01, MA1439NM01, ME051533, ME208350, ME244391, ME244393, MEX68919, MPP0131, MPX46902, MPX47106, MPX52309, MPX82204, MPX99201, MQ1000MN04, MT1014NM01, MT1014NM02, MVINFNM2, N001NU02, N001NU06, NA1027NM01, NASHNM2, NE209938, NM156449, NM18342, NM18346, NM18356, NM18357, NM18363, NM18365, NM18409, NM18444, NM18451, NM18471, NMCR-17849, NMCR-17980, NMINDTCRL0206, NMINDTCRL0227, NMINDTCRL0311, NMINDTCRL0351, NO1000MN03, NO1000MN06, NO1016MN16, NO1054MN01, NO1068MN07, NO1068MN09, NO1070MN07, NO1088MN09, NO1116MN09, NP739716, NPV15964, NUC5178133HM6, O005NU14, OBNM1, ORMCINFINIA1, ORMCINFINIA2, P4211482, PC1268NU03, PC1818NU03, PC3906NU02, PC3964NU02, PC3970NU02, PC5995NU01, PC8118NU01, PER03520, PER08009, PITTINF4, PITTINF5, PK1001NM01, PK1031NM01, PK1032NM01, PK1180NM03, PK1180NM08, PK1184NM01, PK1278NM01, PK1307NM01, PK1335NM01, PK1336NM01, PK1355NM01, PL1003NM03, PL1143NM03, PL1143NM06, PL1692NM01, PM1633NU03, PMR12506, PPR08202, PPR12213, PPR59030, PPR97306, PPS06907, PRINCEINF, R4211480, RO1224NM01, RU1018NM01, RU1021NM02, RU1085NM02, RU1091NM01, RU1095NM02, RU1152NM02, RU1212NM01, RU1284NM01, RU1294NM01, RU1302NM01, RU2050NM01, RU2199NM01, RU2311NM01, RU2311NM02, RU2526NM01, RU2527NM02, RU2527NM03, RU3143NM02, RU3314NM01, RU3424NM01, RU3448NM01, RU3508NM01, S4160059, S4160079, SA1001MN01, SA2146NM01, SLGHINF, TN1366NM01, UC4109NU02, UC7655NU03, UC7655NU04, UE282633, UE282648, UE720407, UEW19003, UEW19005, UK1110NM01, UK5002NM01, UP285A41, UPW00402, V1471114, V2147210, V2728105, V2728109, V2943412, V2943415, V4198004, V6414104, V7405209, V7406615, V7406617, V8572204, VASINF, VCWESTINF, VVMCINF1, X100611101, X105967809, X105967813, X119197203, X151957601, X2034002, X4211026, X59007307, X61014001, Y004NU08, Y004NU11, YE364413, YE364417, YE626937, YN1196, YN1200, YN1539, YN1540, YN1541, YN1542, YN1543, YN1544, YN1545, YN1546, YN1547, YN1548, YN1549, YN1550, YN1551, YN1552, YN1553, YN1554, YN1555, YN1556, YN1557, YN1558, YN1559, YN1560, YN1561, YN1562.YN1563, YN1564, YN1565, YN1566, YN1567, YN1568, YN1569, YN1570, YN1571, YN1572, YN1573, YN1574, YN1575, YN1577, YN1578, YN1579, YN1580, YN1581, YN1582, YN1583, YN1584, YN1585, YN1586, YN1587, YN1588, YN1589, YN1590, YN1591, YN1592, YN1593, YN1594, YN1595, YN1596, YN1597, YN1598, YN1599, YN1600, YN1601, YN1641, YN1650, YN1730, YN1742, YN1743, YN1744, YN1745, YN1760, YN1802, YN4218, YN4219, YN4220, YN4221, YN4222, YN4223, YN4224, YN4225, YN4226, YN4227, YN4228, YN4229, YN4230, YN4231, YN4232, YN4233, YN4234, YN4235, YN4236, YN4237, YN4238, YN4239, YN4240, YN4241, YN4242, YN4243, YN4244, YN4245, YN4248, YN4249, YN4250, YN4251, YN4252, YN4253, YN4254, YN4255, YN4256, YN4257, YN4258, YN4259, YN4260, YN4261, YN4262, YN4263, YN4264, YN4265, YN4266, YN4267, YN4270, YN4280, YN4288, YN4300, YN4312, YN4818, YN4819, YN4820, YN4821, YN4822, YN4824, YN4825, YN4830, YN4833, YN4900, YN4918, YN4919, YN4920, YN4921, YN4922, YN4923, YN4924, YN4925, YN4926, YN4927, YN4928, YN4929, YN4930, YN4931, YN4932, YN4933, YN4934, YN4935, YN4936, YN4937, YN4938, YN4939, YN4941, YN4942, YN4943, YN4944, YN4945, YN4946, YN4947, YN4948, YN4949, YN4950, YN4951, YN4952, YN4953, YN4954, YN4955, YN4990, YN4992, YN4999, YN5000, YN8001, YN8002, YN8003, Z001NU06, ZA1806NM12, ZA1807NM11, ZA1808NM13, ZA1820NM04, ZA1835NM24, ZA1835NM25, ZA2006NM04, ZA2008NM04, ZA2212NM02, ZA2246NM01, ZA2261NM01, ZTP0133, ZWL0437.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.
  • Product Description
    GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices || Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
  • Manufacturer
    GE Healthcare, LLC