No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00857534006547 | InSitu Coil, Open, 1.5T Large | 120018-000 | InSitu Coil, Open, 1.5T Large 120018-000 | MOS | Coil, Magnetic Resonance, Specialty | 2 | InSitu Coil |
2 | 00857534006745 | 120823-000 | IMRIS IMRI 3T V | LNH,LNI,MOS | System, Nuclear Magnetic Resonance Imaging,System, Nuclear Magnetic Resonance Sp System, Nuclear Magnetic Resonance Imaging,System, Nuclear Magnetic Resonance Spectroscopic,Coil, Magnetic Resonance, Specialty | 2 | IMRIS iMRI 3T V | |
3 | 00857534006554 | InSitu Coil, Open, 3T Large | 120019-000 | InSitu Coil, Open, 3T Large, 120019-000 | MOS | Coil, Magnetic Resonance, Specialty | 2 | InSitu Coil |
4 | 00857534006448 | HC150 Lower Coil | LOWER ASSEMBLY, 1.5T IOHv2, SAE, 118995-600 | MOS | Coil, Magnetic Resonance, Specialty | 2 | HC150 - 1.5T Head Coil Lower | |
5 | 00857534006134 | HC150 Lower Coil | LOWER ASSEMBLY, 1.5T IOHv2, SAE, 118995-000 | MOS | Coil, Magnetic Resonance, Specialty | 2 | HC150 - 1.5T Head Coil Lower | |
6 | 00857534006004 | HFD210 | MR/X-ray Head Fixation Device (HFD210),112634-000 | HBL | Holder, Head, Neurosurgical (Skull Clamp) | 2 | MR/X-ray HFD (HFD 210) | |
7 | 00857534006561 | MR Neuro Accessory Adaptor | ORT 400 table MR Neuro Accessory Adaptor- 120025-000 | GDC,KXJ | Table, Operating-Room, Electrical,Table, Radiologic | 1 | ORT 400 (Trumpf TruSystem 7500 MR Neuro) table | |
8 | 00857534006707 | 119900-003 | ORT 400 table, Patient Support Board 119900-003 | KXJ,GDC | Table, Radiologic,Table, Operating-Room, Electrical | 1 | Patient Support Board | |
9 | 00857534006714 | 119749-000 | ORT 400 table, Patient Support Board with Label 119749-000 | KXJ,GDC | Table, Radiologic,Table, Operating-Room, Electrical | 1 | Patient Support Board | |
10 | 00857534006424 | HC300 Lower Coil | Lower Assy, 3T IOH V2, 110840-600 | MOS | Coil, Magnetic Resonance, Specialty | 2 | HC300 -3T Head Coil Lower Assy | |
11 | 00857534006417 | HC300 Upper Assy | Upper Assy, 3T IOH V2, 110833-600 | MOS | Coil, Magnetic Resonance, Specialty | 2 | HC300- 3T Head Coil Upper Assy | |
12 | 00857534006233 | HC300 Upper Assy | Upper Assy, 3T IOH V2, 110833-000 | MOS | Coil, Magnetic Resonance, Specialty | 2 | HC300- 3T Head Coil Upper Assy | |
13 | 00857534006226 | HC300 Lower Coil | Lower Assy, 3T IOH V2, 110840-000 | MOS | Coil, Magnetic Resonance, Specialty | 2 | HC300 -3T Head Coil Lower Assy | |
14 | 00857534006523 | HC150 Lower Coil | LOWER COIL ASSEMBLY, 1.5T Neuro II-S, 119980-000 | MOS | Coil, Magnetic Resonance, Specialty | 2 | HC150 - 1.5T Head Coil Lower Neuro II-S | |
15 | 00857534006219 | iCT System | iCT System 115219-000 | JAK | System, X-Ray, Tomography, Computed | 2 | iCT | |
16 | 00857534006028 | HFD 200 | MR/X-ray Head Fixation Device (HFD200), 113010-000 | HBL | Holder, Head, Neurosurgical (Skull Clamp) | 2 | MR/X-ray HFD (HFD 200) | |
17 | 00857534006486 | ORT100 | T2X OR Table V.2, 110470-600 | FQO,KXJ | Table, Operating-Room, Ac-Powered,Table, Radiologic | 1 | ORT100 Table | |
18 | 00857534006394 | HFD100 | Head Fixation Device HFD100 , 113803-600 | HBL | Holder, Head, Neurosurgical (Skull Clamp) | 2 | Head Fixation Device HFD100 | |
19 | 00857534006370 | InSitu Coil, Open 3T | InSitu Coil, Open, 3T Large, Pouched, 114893-001 | MOS | Coil, Magnetic Resonance, Specialty | 2 | InSitu Coil, 3T | |
20 | 00857534006332 | ORT100 | T2X OR Table V.2, 110470-000 | KXJ,FQO | Table, Radiologic,Table, Operating-Room, Ac-Powered | 1 | ORT100 Table | |
21 | 00857534006189 | iMRX System AR-DR MR30RS | iMRX System AR-DR MR30RS,105824-000 | IZI,LNH | System, X-Ray, Angiographic,System, Nuclear Magnetic Resonance Imaging | 2 | iMRX System | |
22 | 00857534006172 | iMRX System AR-DR-AR | iMRX System AR-DR-AR, MR30R, 105826-000 | IZI,LNH | System, X-Ray, Angiographic,System, Nuclear Magnetic Resonance Imaging | 2 | iMRX System | |
23 | 00857534006165 | iMRX System AR-DR-OR | iMRX System AR-DR-OR, MR30R, 105828-000 | LNH,IZI | System, Nuclear Magnetic Resonance Imaging,System, X-Ray, Angiographic | 2 | iMRX System | |
24 | 00857534006158 | Post Assy, 1.5T 16CH Cardiac Coil | iMRX System Post Assy, 1.5T 16CH Cardiac Coil,105856-000 | IZI,LNH | System, X-Ray, Angiographic,System, Nuclear Magnetic Resonance Imaging | 2 | iMRX System | |
25 | 00857534006141 | ANTERIOR ASSY, 3T 16CH CARDIAC COIL | iMRX System ANTERIOR ASSY, 3T 16CH CARDIAC COIL, 105587-000 | IZI,LNH | System, X-Ray, Angiographic,System, Nuclear Magnetic Resonance Imaging | 2 | iMRX System | |
26 | 00857534006127 | POSTERIOR ASSY, 3T 16CH CARDIAC COIL | iMRX System POSTERIOR ASSY, 3T 16CH CARDIAC COIL, 105589-000 | IZI,LNH | System, X-Ray, Angiographic,System, Nuclear Magnetic Resonance Imaging | 2 | iMRX System | |
27 | 00857534006110 | Ant Assy, 1.5T 16CH Cardiac Coil | iMRX System Ant Assy, 1.5T 16CH Cardiac Coil, 105855-000 | IZI,LNH | System, X-Ray, Angiographic,System, Nuclear Magnetic Resonance Imaging | 2 | iMRX System | |
28 | 00857534006066 | OR-DR 116119-000 | IMRIS SSK OR-DR Full Body Imaging, 116119-000 | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | iMRI 3T S | |
29 | 00857534006059 | OR-DR, 116118-000 | IMRIS SSK OR-DR Partial Body Imaging, 116118-000 | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | iMRI 3T S | |
30 | 00857534006042 | OR-DR-OR 116117-000 | IMRIS SSK OR-DR-OR Full Body Imaging,116117-000 | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | iMRI 3T S | |
31 | 00857534006035 | OR-DR-OR 116053-000 | IMRIS SSK OR-DR-OR Partial Body Imaging, 116053-000 | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | iMRI 3T S | |
32 | 00857534006011 | HFD100 | Head Fixation Device HFD100 , 113803-000 | HBL | Holder, Head, Neurosurgical (Skull Clamp) | 2 | Head Fixation Device HFD100 | |
33 | 00857534006646 | Application Platform 4.0 KIT | Applications Platform 4.0 US/JPN – INT KIT – 3 Room 120087-000 | LMD | System, Digital Image Communications, Radiological | 1 | VISIUSmatrix | |
34 | 00857534006264 | HFD100 Rocker Arm Accessory | Rocker Arm Accessory Kit HFD100, 117948-000 | HBL | Holder, Head, Neurosurgical (Skull Clamp) | 2 | HFD100 Rocker Arm Accessory | |
35 | 00857534006622 | Application Platform 4.0- 3 Room | Applications Platform 4.0 US/JPN – 3 Room- 119897-000 | LMD | System, Digital Image Communications, Radiological | 1 | VISIUSmatrix | |
36 | 00857534006431 | HC150 Lower Assy | Lower Assembly, 1.5T IOHv2 (Es), 110821-600 | MOS | Coil, Magnetic Resonance, Specialty | 2 | HC150 - 1.5T Head Coil Lower Assy | |
37 | 00857534006516 | ORT 400 (Trumpf TruSystem 7500 MR) table | ORT 400 (Trumpf TruSystem 7500 MR) table Assembly, 119493-000 | KXJ,GDC | Table, Radiologic,Table, Operating-Room, Electrical | 1 | ORT 400 (Trumpf TruSystem 7500 MR) table | |
38 | 00857534006509 | ORT 400 (Trumpf TruSystem 7500 MR) Control Panel Assy | ORT 400 (Trumpf TruSystem 7500 MR) table, Control Panel Assy 119409-000 | GDC,KXJ | Table, Operating-Room, Electrical,Table, Radiologic | 1 | ORT 400 (Trumpf TruSystem 7500 MR) table | |
39 | 00857534006462 | ORT300 | ORT300 Modular Table Main Unit Assy, 114093-600 | KXJ,FQO | Table, Radiologic,Table, Operating-Room, Ac-Powered | 1 | ORT300 Table | |
40 | 00857534006356 | ORT300 | ORT300 Modular Table Main Unit Assy, 114093-000 | FQO,KXJ | Table, Operating-Room, Ac-Powered,Table, Radiologic | 1 | ORT300 Table | |
41 | 00857534006325 | Horseshoe Headrest HFD200 Assembly | Horseshoe Headrest HFD200 Assembly, 116343-00 | HBM | Headrest, Neurosurgical | 1 | Horseshoe Headrest | |
42 | 00857534006318 | Horseshoe Headrest HFD100 Assembly | Horseshoe Headrest HFD100 Assembly, 116341-00 | HBM | Headrest, Neurosurgical | 1 | Horseshoe Headrest | |
43 | 00857534006240 | HC150 Lower Assy | Lower Assembly, 1.5T IOHv2 (Es), 110821-000 | MOS | Coil, Magnetic Resonance, Specialty | 2 | HC150 - 1.5T Head Coil Lower Assy | |
44 | 00857534006202 | Neuro III-SV iMRI System | Neuro III-SV Multi-Room Imaging Suite MR30LS Enhancement OR-DR, 116189-000 | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Neuro III-SV iMRI System | |
45 | 00857534006196 | Neuro III-SV iMRI System | Neuro III-SV Multi-Room Imaging Suite MR30RS Enhancement [OR-DR-OR], 118396-000 | LNH | System, Nuclear Magnetic Resonance Imaging | 2 | Neuro III-SV iMRI System | |
46 | 00857534006288 | VISIUSeye iMRI 1.5T A and 3TS | VISIUSeye iMRI 1.5T A and 3TS, 117534-000 | FTY | Tape, Measuring, Rulers And Calipers | 1 | VISIUSeye | |
47 | 00857534006578 | VISIUSeye iMRI 1.5T A and 3TS | 120028-000 | VISIUSeye iMRI 1.5T A and 3TS, 120028-000 | FTY | Tape, Measuring, Rulers And Calipers | 1 | VISIUSeye |
48 | 00857534006639 | Application Platform 4.0- KIT | Applications Platform 4.0 US/JPN – INT KIT-120085-000 | LMD | System, Digital Image Communications, Radiological | 1 | VISIUSmatrix | |
49 | 00857534006479 | ORT200 | ORT200 50/60Hz Covered Table Assy V2, 114148-600 | KXJ,FQO | Table, Radiologic,Table, Operating-Room, Ac-Powered | 1 | ORT200 Table | |
50 | 00857534006387 | InSitu Coil, Open, 1.5T | InSitu Coil, Open, 1.5T Large, Pouched,114892-001 | MOS | Coil, Magnetic Resonance, Specialty | InSitu Coil, 1.5T |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00818089021782 | 90T0021 | Custom Karl Storz, ScaleOR, DVI Input, W/O Fiber, No Accessory, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
2 | 00818089021775 | 90T0020 | ScaleOR, DVI Input, W/O Fiber, W/ DVI and 3G-SDI Cables, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
3 | 00818089021768 | 90T0019 | Custom Brainlab, ConductOR, ND-00B-M11/1 | ScaleOR | NDS SURGICAL IMAGING LLC | |
4 | 00818089021751 | 90T0018 | Custom Karl Storz, ScaleOR, DVI Input, W/O Fiber, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
5 | 00818089021744 | 90T0017 | ConductOR China, ND-00B-M11/1 | ScaleOR | NDS SURGICAL IMAGING LLC | |
6 | 00818089021737 | 90T0016 | ScaleOR, S-Video/Comp Input, W/ Single Fiber, ND-00B-015/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
7 | 00818089021720 | 90T0014 | ScaleOR, VGA Input, W/ Single Fiber, ND-00B-015/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
8 | 00818089021713 | 90T0012 | ScaleOR, SDI Input, W/ Single Fiber, ND-00B-015/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
9 | 00818089021706 | 90T0010 | ScaleOR, DVI Input, W/ Single Fiber, ND-00B-015/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
10 | 00818089020914 | 90V0003 | VIMA VIDEO MANAGER AND RECORDER ND-00D-T19/P | VIMA | NDS SURGICAL IMAGING LLC | |
11 | 00818089020907 | 90T0026 | ScaleOR, S-Video/Comp Input, HDBaseT, ND-00B-021/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
12 | 00818089020891 | 90T0025 | ScaleOR, VGA Input, HDBaseT, ND-00B-021/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
13 | 00818089020884 | 90T0024 | ScaleOR, SDI Input, HDBaseT, ND-00B-021/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
14 | 00818089020877 | 90T0023 | ScaleOR, DVI Input, HDBaseT, ND-00B-021/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
15 | 00818089020433 | 90T0007 | ConductOR, ND-00B-M11/1 | ConductOR | NDS SURGICAL IMAGING LLC | |
16 | 00818089020426 | 90R0036 | RADIANCE G2, 42" full MMI w/fiber | RADIANCE | NDS SURGICAL IMAGING LLC | |
17 | 00818089020365 | D065508 | ConductOR, ND-00B-M11/1 | ConductOR | NDS SURGICAL IMAGING LLC | |
18 | 00818089020143 | 90T0015 | ScaleOR, S-Video/Comp Input, W/O Fiber, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
19 | 00818089020136 | 90T0013 | ScaleOR, VGA Input, W/O Fiber, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
20 | 00818089020129 | 90T0011 | ScaleOR, SDI Input, W/O Fiber, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
21 | 00818089020112 | 90T0009 | ScaleOR, DVI Input, W/O Fiber, ND-00B-014/0 | ScaleOR | NDS SURGICAL IMAGING LLC | |
22 | 00810000890583 | IPS4000 | IPS4000 | Image Processing System | FSN | FORESEESON CUSTOM DISPLAYS, INC. |
23 | 00810000890576 | IPS100A | IPS100A | Image Processing System | FSN | FORESEESON CUSTOM DISPLAYS, INC. |
24 | 00810000890422 | WUH4000 (RX) | WUH4000 (RX) | Wireless Imaging System | FSN | FORESEESON CUSTOM DISPLAYS, INC. |
25 | 00810000890385 | WUH4000 (TX) | WUH4000 (TX) | Wireless Imaging System | FSN | FORESEESON CUSTOM DISPLAYS, INC. |
26 | 00810000890361 | IPS740DG, IPS740DS | IPS740DG, IPS740DS | Image Processing System | FSN | FORESEESON CUSTOM DISPLAYS, INC. |
27 | 00810000890279 | IPS500A | IPS500A | Image Processing System | FSN | FORESEESON CUSTOM DISPLAYS, INC. |
28 | 00628105001830 | 8.3 | EasyViz is a software only medical device providing tools and features that may EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data fromvarious imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. EasyViz enables healthcareprofessionals and physicians to access patients’ medical images for making all patient management decisions. | EasyViz | CANON MEDICAL INFORMATICS A/S | |
29 | 00628105001823 | 8.2 | EasyViz is a software only medical device providing tools and features that may EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data fromvarious imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. EasyViz enables healthcareprofessionals and physicians to access patients’ medical images for making all patient management decisions. | EasyViz | CANON MEDICAL INFORMATICS A/S | |
30 | 00628105001816 | 8.1 | EasyViz is a software only medical device providing tools and features that may EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data fromvarious imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. EasyViz enables healthcareprofessionals and physicians to access patients’ medical images for making all patient management decisions. | EasyViz | CANON MEDICAL INFORMATICS A/S | |
31 | 00628105001809 | 8.0 | EasyViz is a software only medical device providing tools and features that may EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data fromvarious imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. EasyViz enables healthcareprofessionals and physicians to access patients’ medical images for making all patient management decisions. | EasyViz | CANON MEDICAL INFORMATICS A/S | |
32 | 00628105001779 | 7.7 | EasyViz is a diagnostic software image display workstation that has the ability EasyViz is a diagnostic software image display workstation that has the ability to work with EMR Systems. Powered by our unique adaptive streaming technology, it delivers simple and fast access to diagnostic quality imaging information when and where needed by Radiologists, Cardiologists, Clinicians and referring Physicians. | EasyViz | CANON MEDICAL INFORMATICS A/S | |
33 | 00628105001021 | 8.3.9 | EasyViz is a software only medical device providing tools and features that may EasyViz is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data fromvarious imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. EasyViz enables healthcareprofessionals and physicians to access patients’ medical images for making all patient management decisions. | EasyViz | CANON MEDICAL INFORMATICS A/S | |
34 | 00628105001007 | 8.4 | Vitrea Read is a software only medical device providing tools and features that Vitrea Read is a software only medical device providing tools and features that may be used for general-purpose radiological viewing and reading (diagnosis) of image data from various imaging modalities, clinical review and performs functions of digital image processing, measurement, communications and storage. Vitrea Read enables healthcare professionals and physicians to access patients’ medical images for making all patient management decisions. | Vitrea Read | CANON MEDICAL INFORMATICS A/S | |
35 | 00616258026428 | CAL-VIEWER | CAL-VIEWER | Calantic Viewer (88439783) | Calantic Viewer | BAYER MEDICAL CARE INC. |
36 | B295VNA70 | 7 | PACSCore VNA archive with remote, remote backup, and optional local repositories PACSCore VNA archive with remote, remote backup, and optional local repositories, and ConnectWeb on remote archive | Vendor Neutral Archive with ConnectWeb | RADIUS | |
37 | B295VBB60 | 6 | Basic radiologist workstation | ViewBox Basic | RADIUS | |
38 | B295VBA10 | 1 | Advanced radiologist workstation | ViewBox Advanced | RADIUS | |
39 | B295PACSCORE60 | 6 | PACSCore back-end archive | PACSCore | RADIUS | |
40 | B295FULLPACS30 | 3 | ConnectWeb viewer front-end with PACSCore back-end archive | ConnectWeb with PACSCore | RADIUS | |
41 | B295DICOMFWD30 | 3 | Basic DICOM gateway | DicomForward | RADIUS | |
42 | B220843002A8430031 | Eureka AI Interoperability Platform | An application software program designed to function as a portal to allow softwa An application software program designed to function as a portal to allow software providers to make available radiological interpretive software [typically artificial intelligence (AI) based] for radiology professionals to access, use, evaluate, and compare. It is intended to facilitate distribution and hospital implementation of algorithms designed to assist image interpretation within a healthcare facility. | Eureka | TERARECON INC. | |
43 | B2208430011 | Eureka AI Results Explorer | Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms. | Eureka | TERARECON INC. | |
44 | AMBRMOBILEAPP0 | AMBRMOBILEAPP0 | Mobile Application version of Ambra Health. Not intended for diagnostic purposes. | Ambra Health Mobile Application | AMBRA HEALTH | |
45 | 60889978671366 | Vue RIS | 8671364 | RIS SOFTWARE < 25K EXAMS / YEAR | Vue RIS | CARESTREAM HEALTH, INC. |
46 | 60889976574645 | DRX - Ascend System | 6574644 | QG-TV-CM | DRX - Ascend System | CARESTREAM HEALTH, INC. |
47 | 60889976574638 | DRX - Ascend System | 6574636 | QG-TV10-C TECHVISION RS-590 WITH Q-VISIO | DRX - Ascend System | CARESTREAM HEALTH, INC. |
48 | 60889976573341 | QG-TV-IP-FM | 6573349 | QG-TV10-IPF-MAT TECHVISION QS-550 DRX AT | QG-TV-IP-FM | CARESTREAM HEALTH, INC. |
49 | 60889976573334 | QG-TV-IP-F | 6573331 | QG-TV10-IPF TECHVISION QS-550 WITH DRX | QG-TV-IP-F | CARESTREAM HEALTH, INC. |
50 | 60889976573327 | QG-TV-IP-CM | 6573323 | QG-TV10-IPC-MAT TECHVISION RS-590 DRX AT | QG-TV-IP-CM | CARESTREAM HEALTH, INC. |