Lot 79440009

Radiology Devices

1

No

US Nationwide Distribution in the states of: AL, AZ, CA, LA, MI, NE, NH, NJ, NC, VA

Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM

Lot Batch No. 79350052, 79380052, 79390074, 79400066, 79410063

Radiology Devices

1

No

Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada

Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF || Product Usage: Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.

A5410000053, A5410000054, A5411000439, A5411000446, A5411000447, A5411000448, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A5410000100, A5410000107, A5410000134, A5411000184, A5410000039, A5411000140, A5411000142, A5411000314, A5411000342, A5411000347, A5411000349, A5410000007, A5411000017, A5411000315, A5411000331, A5411000332, A5411000463, A5411000141, A5411000144, A5411000539, A5411000541, A5411000069, A5411000133, A5411000175, A5411000119, A5411000123, A5411000019, A5411000400, A5411000401, A5411000540, A5411000047, A5411000048, A5411000053, A5410000041, A5410000042, A5410000046, A5411000041, A5411000079, A5411000024, A5411000032, A5411000083, A5411000038, A5411000132, A5411000571, A5411000573, A5411000050, A5411000088, A5411000247, A5411000070, A5411000078, A5411000082, A5411000476, A5411000478, A5411000480, A5411000482, A5411000489, A5411000490, A5411000563, A5411000582, A5411000154, A5411000156, A5411000404, A5411000500, A5411000501, A5411000589, A5411000591, A5411000583, A5411000236, A5411000155, A5411000151, A5411000191, A5411000192, A5411000194, A5411000193, A5411000249, A5411000052, A5411000185, A5411000237, A5411000030, A5411000397, A5411000587, A5411000499, A5411000503, A5411000504, A5411000574, A5411000584, A5411000348, A5411000193, A5411000268, A5411000498, A5411000502, A5411000509, A5411000403, A5411000153, A5411000233, A5411000235, A5411000318, A5411000398, A5411000538, A5411000371, A5410000043, A5411000181, A5411000158, A5411000513, A5411000514, A5411000152, A5411000548, A5411000553, A5411000199, A5411000209, A5411000210, A5411000232, A5411000346, A5411000124, A5411000174, A5411000177, A5411000230, A5411000468, A5411000469, A5411000470, A5411000173, A5411000316, A5411000145, A5411000188, A5411000197, A5411000202, A5411000203, A5411000206, A5411000208, A5411000335, A5411000336, A5411000533, A5411000537, A5411000536, A5411000159, A5410000038, A5411000148, A5411000149, A5411000134, A5411000405, A5411000120, A5411000125, A5411000372, A5411000147, A5411000588, A5411000039, A5411000117, A5411000121, A5411000333, A5411000334, A5411000377, A5411000040, A5411000240, A5411000593, A5411000594, A5411000085, A5411000419, A5411000097, A5411000281, A5411000278, A5411000279, A5411000280, A5411000492, A5411000282, A5411000245, A5411000277, A5411000064, A5411000065, A5411000187, A5411000198, A5411000207, A5411000211, A5411000212, A5411000231, A5411000399, A5411000491, A5411000493. A5411000524, A5411000497, A5411000534, A5411000526, A5411000535, A5411000122, A5411000575, A5411000576, A5411000577, A5411000495, A5411000578, A5410000044, A5411000037, A5411000241, A5411000246, A5411000108, A5411000110, A5411000114, A5411000312, A5411000074, A5411000080, A5411000522, A5411000033, A5411000139, A5411000543, A5411000182, A5411000190, A5411000021, A5411000374, A5411000218, A5411000572, A5411000084, A5411000098, A5411000238, A5411000116, A5411000408, A5411000409, A5410000042, A5410000023, A5411000544, A5411000580, A5411000581, A5411000545, A5411000546, A5411000547, A5411000579, A5411000337, A5411000338, A5411000340, A5411000341, A5411000475, A5411000549, A5411000373, A5411000420, A5410000133, A5410000117, A5410000115, A5410000079, A5410000131, A5410000066, A5410000132, A5410000114, A5410000082, A5410000116, A5411000025, A5411000523, A5411000525, A5411000590, A5411000592, A5411000263, A5411000309, A5411000262, A5411000270, A5411000272, A5411000273, A5411000293, A5411000363, A5411000260, A5411000264, A5411000269, A5411000271, A5411000291, A5411000292, A5411000261, A5411000265, A5411000266, A5411000267, A5411000034, A5411000081, A5411000146, A5411000092, A5411000093, A5411000407, A5411000026, A5411000068, A5411000367, A5411000368, A5411000465, A5411000060, A5411000131, A5411000018, A5411000100, A5411000515, A5411000313, A5411000284, A5411000076, A5411000135, A5411000180, A5411000343, A5411000285, A5411000311, A5411000375, A5411000062, A5411000136, A5411000179, A5411000178, A5411000421, A5411000427, A5411000376

Radiology Devices

2

No

Worldwide Distribution - US including AL, AR, CA, CO, DC, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, OH, OK, OR, RI, SC, TN, TX, VA, WV, WI, WY, and Internationally to Canada.

AGFA Digital Radiography X-Ray System DX-D100 || DX-D100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis

A5430000264, A5430000272, A5430000162, A5430000238, A5430000226, A5430000137, A5430000306, A6430000298, A5430000299, A5430000246, A5430000247, A5430000249, A5430000303, A5430000228, A5430000229, A5430000304, A5430000234, A5430000276, A5430000285, A5430000296, A5430000300, A5430000015, A5430000124, A5430000125, A5430000095, A5430000144, A5430000156, A5430000206, A5430000207, A5430000061, A5430000100, A5430000053, A5430000079, A5430000225, A5430000248, A5430000027, A5430000030, A5430000042, A5430000052, A5430000066, A5430000068, A5430000081, A5430000085, A5430000096, A5430000131, A5430000132, A5430000224, A5430000297, A5430000166, A5430000222, A5430000054, A5430000263, A5430000057, A5430000119, A5430000133, A5430000176, A5430000177, A5430000184, A5430000295, A5430000275, A5430000279, A5430000107, A5430000108, A5430000293, A5430000063, A5430000020, A5430000074, A5430000045, A5430000121, A5430000089, A5430000143, A5430000218, A5430000199, A5430000149, A5430000060, A5430000165, A5430000067, A5430000130, A5430000305, A5430000215, A5430000237, A5430000058, A5430000105, A5430000106, A5430000172, A5430000183, A5430000242, A5430000281

Radiology Devices

2

No

AL, CA, DC, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, NV, NJ, NM, NY, OH, OK, OR, SC, TN, TX, VA, and Canada

DX-D600 - DXD Imaging Package

Versions CV 12.2 SU3, CV 12.2 SU4, CV 12.2 SU5 and CV 12.2 SU6

Radiology Devices

2

No

Nationwide Distribution to NJ, NC, OH, PA, SC, TN, TX, and WI

IMPAX Cardiovascular || The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats

2UA15205XC, 2UA161JNH, A5411002007, A5411001003, A5411001002, 5CG5164040, 2UA5481BVY, 5CG5171X81, A5411002026, A5411002025, A5410000039, 2UA62524PS, 2UA62524Q2, 2UA62524RK, A5411002031, 2UA61218G4, 5CG61266X6, 2UA61218GG, 2UA63825HQ, 2UA642306H, 2UA4161JMY, 2UA52524Y5, 2UA62524RJ, 2UA62524QV, 2UA62524QB, 2UA62524RJ, 2UA62524NS, 2UA62524PJ, 2UA62524Q9, A5411000155, A5411000151, 2UA62524PH, 2UA62524QL, 2UA62524QT, A5411000153, 2UA62524Q0, 5CG6126B9J, 5CG61266YW, 5CG61266VP, 5CG61268BG, 5CG612673N, 2UA6243GNY, 2UA62424R8, 2UA62524P4, 2UA62524RY, 2UA6243GPT, 2UA62524Q6, 2UA62524PR, A5411000152, 2UA63825HR, 2UA31000Q6, 2UA31000Q8, 2UA31000R5, 2UA31000QR, 2UA319120W, 2UA3191211, 2UA31000PS, 2UA31000QX, 2UA31000Q0, 2UA31000PX, A5411000346, A5411000232, A541000199, A5411000210, A5411000209, 2UA62524P8, 5CG61266R5, 5CG5295760, 5CG5285W67, 5C5285W7P, 5CG5285W9Y, 5CG5285W5R, 5CG528W7B, A5411001163, A5411000468, 2UA52524XM, 2UA5481BTP, A5411000145, 2UA25009HM, A5411001064, A5411000159, 2UA3380VMW, 2UA3380VMG, 2UA3461QSD, A5411001039, A5411001066, A5411001065, A5411000230, A5411000177, A5411000174, CZC6349KSZ, 2UA62524RH, 2UA62524R4, 2UA6254Q7, A5411000116, A5411002095, A5411002093, A5411002092, A5411001173, A5411001172, 2UA6243GPK, 2UA6243GPL, 2UA62524QH, 2UA4150QFZ, 2UA4150QFQ, 2UA1110ZYG, 2UA3021KYP, 2UA52524XC, 2UA52524YK, 2UA52524YQ, A5411001105, MXL24220J8, A5411002030, A5411001089, A5411002058, 2UA2181HSV, A5411000238, 2UA6021JXG, 2UA511BZ2, A5411000341, A5411000340, A5411000337, 2UA5111C0V, CZ6357GKR, CZC6357GFM, A5411002051, A5411002048, A5411002047, A5411002052, A5411002049, A5411000549, 2UA62524RW, 2UA62524QS, 2UA62524P7, 2UA62524R7, 2UA62524QM, A5410001000, A5410000132, 2UA5170ZKM, 2UA5422QN4, 2UA62524PP, 2UA62524R6, 2UA1221B32, 2UA62524QD, A5411002033, 2UA62524RX, 5CG6126743, 2UA62524PB, 2UA44616DJ, 2UA63825J3, 2UA62524P6, 2UA62524QF, 2UA62524PL, 5CG61266QW, 2UA62524PN, 2UA62524RS, 2UA62524RQ, 2UA62524QJ, 5C61266Y4, A5411002064, A54110002059, CZC6349KXK, 2UA5111BZC, 2UA642306K, 2UA63825J4, 2UA64029N9, 2UA62524PD, 2UA62524P1, 2UA62524Q8, 2UA63825J6, 2UA63825JD, 2UA62524P0, 2UA63825HS, 2UA63825HN, 2UA63825J5, 2UA63825J8, 2UA61225X9, 2UA62524PT, 2UA63825J0, 2UA62524PV, 2UA5111BYZ, 5CG61266YZ, 2UA62524NY, 2UA62524RV, 5CG61266MG, 2UA63825JC, 2UA63825HX, 2UA62524QZ, 2UA62524QR, 2UA62524PF, 5CG53032V5, 2UA52223Q2, 2UA52223Q4, 2UA51519JR, 2UA62524RP, 2UA32878M, 2UA5451JKP, 2UA62524RG, 2UA62524R5, 2UA62524RN, 2UA63825HM, A5411002022, A45411000018, A5411002057, 2UA63825HZ, A5411000180, 2UA15205X9, 2UA62524NX, 2UA31000Q9, A5411000179, 2UA5451JL2, 2UA1510H6B, 2UA5311CS3, 2UA61218GT, CZC6057ZSL, A5411002024, 2UA62524RM, 2UA62524PY, 2UA1510H60, 2UA1510H5C

Radiology Devices

2

No

AL, AZ, AR, CA, DC, FL, GA, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WV and Canada

Agfa Healthcare NX 3.0.8950 Imaging Processing Software

Serial Nos. A5430000089, A5430000131, A5430000015, A5430000095, A5430000052, A5430000061, A5430000079, A5430000030, A5430000042, A5430000066, A5430000081, A5430000085, A5430000096, A5430000020, A5430000067, A5430000125, A5430000105

Radiology Devices

2

No

Worldwide Distribution - US Natinwide in the state of GA, IN, KS, KY, MA, NJ, SC, VA, DC and the country of Canada

DX-D 600 - DXD Imaging Package || Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.

Serial Number A5410000042

Radiology Devices

2

No

US in the state of WV

Agfa Digital Radiography X-Ray System DX-D 100 || Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.

A5410000053, A5410000054, A5411000439, A5411000446, A5411000447, A5411000448, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A5411000420, A5410000100, A5410000107, A5410000114, A5410000115, A5410000116, A5410000117, A5410000132, A5410000133, A5410000134, A5410000039, A5411000140, A5411000142, A5411000314, A5411000342, A5411000347, A5411000349, A5410000007, A5411000017, A5411000315, A5411000331, A5411000332, A5411000463, A5411000141, A5411000144, A5411000069, A5411000133, A5411000175, A5411000119, A5411000123, A5411000019, A5411000400, A5411000401, A5411000047, A5411000048, A5411000053, A5410000041, A5411000042, A5411000046, A5411000041, A5411000079, A5411000024, A5411000038, A5411000083, A5411000032, A5411000132, A5411000247, A5411000088, A5411000050, A5411000070, A5411000078, A5411000082, A5411000476, A5411000478, A5411000480, A5411000482, A5411000489, A5411000490, A5411000154, A5411000156, A5411000404, A5411000236, A5411000155, A5411000151, A5411000191, A5411000192, A5411000194, A5411000196, A5411000249, A5411000052, A5411000185, A5411000237, A5411000030, A5411000397, A5411000348, A5411000193, A5411000268, A5411000403, A5411000153, A5411000233, A5411000235, A5411000318, A5411000398, A5411000371, A5410000043, A5411000181, A5411000158, A5411000152, A5411000309, A5411000263, A5411000199, A5411000209, A5411000210, A5411000232, A5411000346, A5411000124, A5411000174, A5411000177, A5411000230, A5411000468, A5411000469, A5411000470, A5411000173, A5411000316, A5411000145, A5411000188, A5411000197, A5411000202, A5411000203, A5411000206, A5411000208, A5411000335, A5411000338, A5411000159, A5410000038, A5411000148, A5411000149, A5411000134, A5411000125, A5411000147, A5411000039, A5411000121, A5411000405, A5411000372, A5411000120, A5411000117, A5411000333, A5411000334, A5411000040, A5411000377, A5411000240, A5411000085, A5411000419, A5411000097, A5411000281, A5411000278, A5411000279, A5411000492, A5411000280, A5411000282, A5411000245, A5411000277, A5411000184, A5411000064, A5411000065, A5411000187, A5411000198, A5411000207, A5411000211, A5411000212, A5411000231, A5411000399, A5411000491, A5411000493, A5411000122, A5411000495, A5411000312, A5410000044, A5411000037, A5411000108, A5411000110, A5411000114, A5411000241, A5411000246, A5411000074, A5411000080, A5411000033, A5411000139, A5411000182, A5411000190, A5411000021, A5411000374, A5411000218, A5411000084, A5411000098, A5411000238, A5411000116, A5411000408, A5411000409, A5410000042, A5411000023, A5411000337, A5411000338, A5411000340, A5411000341, A5411000475, A5411000373, A5410000079, A5410000131, A5410000066, A5410000082, A5411000025, A5411000262, A5411000270, A5411000272, A5411000273, A5411000293, A5411000363, A5411000260, A5411000264, A5411000269, A5411000271, A5411000291, A5411000292, A5411000261, A5411000265, A5411000266, A5411000267, A5411000034, A5411000081, A5411000146, A5411000092, A5411000093, A5411000407, A5411000026, A5411000068, A5411000367, A5411000368, A5411000465, A5411000060, A5411000131

Radiology Devices

2

No

US Distribution to the states of : AL, CA, DC, FL, GA, IL, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NJ, NY, NC, OH, OK, OR, SC, TN, TX, VA, WV, WI and WY.

AGFA DX-D 100 is a mobile digital radiography x-ray system

Model # L9M2100

Radiology Devices

2

No

Distributed in the states of CA, KY, NH, NY, NC, OH, OR, PA, SC, SD, TN, TX, WA and the country of Canada.

IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed.

Radiology Devices

2

No

Distributed in the state of MO.

IMPAX Agility. || IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.

Model: DX-D600, Affected: 5430/120

Model: DX-100 Mobile X-Ray, Affected:

Model: , Affected: Software 3.0.8950

md

IMPAX RIS QDoc Software version 5.8 and later

The IMPAX RIS (radiology information system) system manages all radiology tasks electronically, from the beginning to the end, including requesting and scheduling examinations, creating protocols, registering patients, establishing work lists, preparing medical reports, transcription , business intelligence and distribution of results.

md

md

IMPAX 6.5.x

The IMPAX RIS (RADIOLOGY INFORMATION SYSTEM) system manages all deradiology tasks electronically, from the beginning to the end, including the application and programming of exams, creation of protocols, registration of patients, establishment of work lists, preparation of medical reports, transcription, Businessintelligence and distribution of results.

DX-D600

It allows to capture and process a wide range of studies with greater productivity thanks to the image quality, in an agile way it is passed to direct radiology, ideal for the study of external and internal patients, small hospitals and radiological imaging centers, emergency room, orthopedic centers and clinics private, as well as medical consultations allow to reduce the doses applied to the patient, thanks to cesium iodide technology, and does so for DR as for CR based on water technology is easily installed in limited spaces requires minimal training, provides a wide range of images in a short time

DX-D100

It allows to capture and process a wide range of studies with greater productivity thanks to the image quality, in an agile way it is passed to direct radiology, ideal for the study of external and internal patients, small hospitals and radiological imaging centers, emergency room, orthopedic centers and clinics private, as well as medical consultations allow to reduce the doses applied to the patient, thanks to cesium iodide technology, and does so for DR as for CR based on water technology is easily installed in limited spaces requires minimal training, provides a wide range of images in a short time

Model: , Affected: , Software version: Version 5.8 and higher

Model: , Affected: All units

Model: Model: DX-D600, Affected:

Model: Type 5410 or 5411, Affected: