Allura Xper

Devices are identified with Site Numbers:  14147, 38377, 505254, 544048, 544051, 548067, 549738, 550172, 552470, 552585, 552586, 553234, 553351, 553352, 553925, 554019, 554427, 554431, 554442, 554444, 554550, 554556, 554631, 554745, 554768, 554791, 555206, 556311, 556708, 556783, 557512, 41416358, 41443581, 41443882, 41444662, 41445645, 41446080, 41446144, 41446290, 41446807, 41455906, 41903960, 42393465, 43067304, 43719245, 44048177, and 44604746.

Radiology Devices

2

No

Devices were distributed to hospitals and medical facilities through out the U.S.

Allura Xper FD10 Monoplane X-ray system. || Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems.

Devices are identified with Site Numbers:  103281, 103283, 505903, 506119, 530653, 536715, 543411, 545396, 547823, 549368, 552969, 554802, 554970, 555293, 555299, 555834, 41443647, 41443804, 41444650, 41445448, 41445501, 41445538, 41455920, 41780160, 42057324, and 42064724.

Radiology Devices

2

No

Devices were distributed to hospitals and medical facilities through out the U.S.

Allura Xper FD10/10 Biplane X-ray system. || Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement and atherectomies), pacemaker implantations and electrophysiology. It is compatible with specified magnetic navigation systems.

FCO 72200124 and 72200125 for 1st phase FCO 72200133 for 2nd phase Equipment #'s: 103281, 103283, 505903, 506119, 530653, 532614, 533397, 536028, 536031, 536034, 536035, 536037, 536042, 536171, 536715, 536789, 536899, 537631, 537804, 538028, 538157, 538387, 538409, 538514, 538516, 539326, 539628, 540184, 540237, 541577, 541589, 541590, 542413, 542557, 542714, 543200, 543289, 543411, 543879, 543989, 544395, 544433, 545025, 545396, 545604, 545753, 545884, 545997, 546013, 546569, 547173, 547769, 547823, 547922, 548140, 548288, 549368, 549903, 551855, 554802, 554970, 555293, 555299, 555834, 41443647, 41443804, 41444647, 41444650, 41445448, 41445501, 41445538, 41455885, 41455897, 41455920, 41780160, 42057324, and 42064724.   Additional Equipment #s from phase 2- 10107, 101110, 101205, 557729, 557908, 41443609, 41445432, 41446024, 41446262, 41660520, 42046440, 42064058, 42394072, 42553772, 42625859, 42891704, 43043666, 43164789, 43173591, 43453735, 43848923, 43931292, 44028554, 44066424, 44193760, 44892370, and 47140511.

Radiology Devices

2

No

Worldwide Distribution

Allura XPER 10/10

FCO 72200122 and 72200123 for the 1st phase 72200133 for the 2nd phase Equipment #'s  548432, 549242, 555356, 41443586, 41443727, 41443765, 41443909, 41444645, 41444752, 41444816, 41455925, 41455953, 42046093, 41445118 547914, 552599, 41455933, 504674, 534156, 538095, 538099, 538481, 539213, 540461, 541276, 542963, 543690, 543953, 544306, 544543, 544635, 544656, 544668, 544844, 545518, 545583, 545882, 546119, 546149, 546906, 547215, 547431, 547642, 547715, 548005, 548020, 548036, 548082, 548383, 548618, 549202, 549370, 550198, 550691, 550758, 550812, 550935, 552355, 552639, 553685, 553699, 553766, 558604, and 41444689.  Additional Equipment #s from Phase 2 - 85130, 85634, 86450, 86584, 86985, 87317, 87359, 100812, 102908, 102937, 102974, 103381, 103722, 104341, 558945, 41443627, 41445615, 41445628, 41446230, 41446773, 41455944, 41793290, 41796154, 42067824, 42479274, 42508759, 42735090, 42891020, 42891095, 43058934, 43315510, 43436747, 43443622, 43635004, 43670742, 44616211, and 44735751.

Radiology Devices

2

No

Worldwide Distribution

Allura XPER FD20/10