No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00628451892021 | 1 | P008943 | The Halifax Imaging Kit is part of the SR Suite product line, provides an altern The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path tocreating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Raycomponents integrated into an existing digital radiography room already containing an FDAcleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kitand the existing DR system are synchronized by replacing the trigger switches of the twosystems with the Halifax Synchronization Switch. The Halifax Synchronization Switchensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray imagesfrom two different perspectives to be taken at the exact same time. This process allows forRoentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR).RSA is a stereo x-ray technique that enables measurements more accurate and precise thansingle plane radiography based on phantom studies. The increased level of precision enablesmeasurement of implant stability. | MQB,LLZ,KPR | Solid State X-Ray Imager (Flat Panel/Digital Imager),System, Image Processing, R Solid State X-Ray Imager (Flat Panel/Digital Imager),System, Image Processing, Radiological,System, X-Ray, Stationary | 2 | Halifax Imaging Kit |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 05420045503994 | SMARK-M-SS3 | SMARK-M-SS3 | SecurMark MRI | HOLOGIC, INC. | |
2 | 05420045503987 | SMARK-M-SS2 | SMARK-M-SS2 | SecurMark MRI | HOLOGIC, INC. | |
3 | 05420045503970 | SMARK-M-SS1 | SMARK-M-SS1 | SecurMark MRI | HOLOGIC, INC. | |
4 | 05420045503963 | SMARK-E10-SS3 | SMARK-E10-SS3 | SecurMark | HOLOGIC, INC. | |
5 | 05420045503956 | SMARK-E10-SS2 | SMARK-E10-SS2 | SecurMark | HOLOGIC, INC. | |
6 | 05420045503949 | SMARK-E10-SS1 | SMARK-E10-SS1 | SecurMark | HOLOGIC, INC. | |
7 | 05420045503932 | SMARK-E13-SS3 | SMARK-E13-SS3 | SecurMark | HOLOGIC, INC. | |
8 | 05420045503925 | SMARK-E13-SS2 | SMARK-E13-SS2 | SecurMark | HOLOGIC, INC. | |
9 | 05420045503918 | SMARK-E13-SS1 | SMARK-E13-SS1 | SecurMark | HOLOGIC, INC. | |
10 | 05420045503901 | SMARK-U-SS3 | SMARK-U-SS3 | SecurMark | HOLOGIC, INC. | |
11 | 05420045503895 | SMARK-U-SS2 | SMARK-U-SS2 | SecurMark | HOLOGIC, INC. | |
12 | 05420045503888 | SMARK-U-SS1 | SMARK-U-SS1 | SecurMark | HOLOGIC, INC. | |
13 | 05420045503871 | SMARK-A1309-SS2 | SMARK-A1309-SS2 | SecurMark for ATEC | HOLOGIC, INC. | |
14 | 05420045503864 | SMARK-A1309-SS1 | SMARK-A1309-SS1 | SecurMark for ATEC | HOLOGIC, INC. | |
15 | 05420045503857 | SMARK-A1312-SS2 | SMARK-A1312-SS2 | SecurMark for ATEC | HOLOGIC, INC. | |
16 | 05420045503840 | SMARK-A1312-SS1 | SMARK-A1312-SS1 | SecurMark for ATEC | HOLOGIC, INC. | |
17 | 05420045503833 | SMARK-A3609-SS3 | SMARK-A3609-SS3 | SecurMark for ATEC | HOLOGIC, INC. | |
18 | 05420045503826 | SMARK-A3609-SS2 | SMARK-A3609-SS2 | SecurMark for ATEC | HOLOGIC, INC. | |
19 | 05420045503819 | SMARK-A3609-SS1 | SMARK-A3609-SS1 | SecurMark for ATEC | HOLOGIC, INC. | |
20 | 05420045503628 | SMARK-EVIVA-2S-13 | SMARK-EVIVA-2S-13 | SecurMark | HOLOGIC, INC. | |
21 | 05420045503611 | SMARK-EVIVA-13 | SMARK-EVIVA-13 | SecurMark | HOLOGIC, INC. | |
22 | 05420045503604 | SMARK-EVIVA-2S-10 | SMARK-EVIVA-2S-10 | SecurMark | HOLOGIC, INC. | |
23 | 05420045503598 | SMARK-EVIVA-10 | SMARK-EVIVA-10 | SecurMark | HOLOGIC, INC. | |
24 | 05420045503581 | TRIMARK-EVIVA-2S-13 | TRIMARK-EVIVA-2S-13 | TriMark | HOLOGIC, INC. | |
25 | 05420045503574 | TRIMARK-EVIVA-13 | TRIMARK-EVIVA-13 | TriMark | HOLOGIC, INC. | |
26 | 05420045503567 | TRIMARK-EVIVA-2S-10 | TRIMARK-EVIVA-2S-10 | TriMark | HOLOGIC, INC. | |
27 | 05420045503550 | TRIMARK-EVIVA-10 | TRIMARK-EVIVA-10 | TriMark | HOLOGIC, INC. | |
28 | 05420045503482 | SMARK-ATEC-2S-36-12 | SMARK-ATEC-2S-36-12 | SecurMark for ATEC | HOLOGIC, INC. | |
29 | 05420045503475 | SMARK-ATEC-36-12 | SMARK-ATEC-36-12 | SecurMark for ATEC | HOLOGIC, INC. | |
30 | 05420045503468 | SMARK-ATEC-2S-36-09 | SMARK-ATEC-2S-36-09 | SecurMark for ATEC | HOLOGIC, INC. | |
31 | 05420045503451 | SMARK-ATEC-36-09 | SMARK-ATEC-36-09 | SecurMark for ATEC | HOLOGIC, INC. | |
32 | 05420045503444 | SMARK-ATEC-2S-13-12 | SMARK-ATEC-2S-13-12 | SecurMark for ATEC | HOLOGIC, INC. | |
33 | 05420045503437 | SMARK-ATEC-13-12 | SMARK-ATEC-13-12 | SecurMark for ATEC | HOLOGIC, INC. | |
34 | 05420045503420 | SMARK-ATEC-2S-13-09 | SMARK-ATEC-2S-13-09 | SecurMark for ATEC | HOLOGIC, INC. | |
35 | 05420045503413 | SMARK-ATEC-13-09 | SMARK-ATEC-13-09 | SecurMark for ATEC | HOLOGIC, INC. | |
36 | 05420045503406 | SMARK-CELERO-2S | SMARK-CELERO-2S | SecurMark | HOLOGIC, INC. | |
37 | 05420045503390 | SMARK-CELERO | SMARK-CELERO | SecurMark | HOLOGIC, INC. | |
38 | 05420045503383 | CELEROMARK-2S | CELEROMARK-2S | CELEROMARK | HOLOGIC, INC. | |
39 | 05420045503376 | CELEROMARK | CELEROMARK | CELEROMARK | HOLOGIC, INC. | |
40 | 05420045503369 | TRIMARKTD-2S-36-12 | TRIMARKTD-2S-36-12 | TriMark | HOLOGIC, INC. | |
41 | 05420045503352 | TRIMARKTD-2S-36-09 | TRIMARKTD-2S-36-09 | TriMark | HOLOGIC, INC. | |
42 | 05420045503345 | TRIMARKTD-2S-13-MR | TRIMARKTD-2S-13-MR | TriMark | HOLOGIC, INC. | |
43 | 05420045503338 | TRIMARKTD-2S-13-12 | TRIMARKTD-2S-13-12 | TriMark | HOLOGIC, INC. | |
44 | 05420045503321 | TRIMARKTD-2S-13-09 | TRIMARKTD-2S-13-09 | TriMark | HOLOGIC, INC. | |
45 | 05420045503314 | TRIMARK TD 3612 | TRIMARK TD 3612 | TriMark | HOLOGIC, INC. | |
46 | 05420045503307 | TRIMARK TD 3609 | TRIMARK TD 3609 | TriMark | HOLOGIC, INC. | |
47 | 05420045503291 | TRIMARK TD 13MR | TRIMARK TD 13MR | TriMark | HOLOGIC, INC. | |
48 | 05420045503284 | TRIMARK TD 1312 | TRIMARK TD 1312 | TriMark | HOLOGIC, INC. | |
49 | 05420045503277 | TRIMARK TD 1309 | TRIMARK TD 1309 | TriMark | HOLOGIC, INC. | |
50 | 04250195611932 | 351282 | Tumark Professional | SOMATEX MEDICAL TECHNOLOGIES GMBH |