No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 60889978869848 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen | 8869844 | 24X30CM CR MAMMO SCR EHR-M3 | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M3 Screen |
2 | 60889978806324 | MIN-R 2 Cassette with MIN-R EV 190 Screen | 8806325 | 24X30CM MIN-R2 CASS W/EV 190 SCR | EAM,IXA | Screen, intensifying, radiographic,Cassette, radiographic film | 1 | MIN-R 2 Cassette with MIN-R EV 190 Screen |
3 | 60889978712878 | READYMATIC Fixer and Replenisher | 8712879 | READYMATIC Fixer and Repl - 4x1GL | IWZ | Film, radiographic | 1 | READYMATIC Fixer and Replenisher |
4 | 60889978622795 | CARESTREAM DRX-1 System | 8622797 | CARESTREAM DRX-1 SYSTEM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | CARESTREAM DRX-1 System |
5 | 60889978621668 | Value Systems | 8621666 | GENERATOR GRP D 50KW 3P 208-240 VAC | KPR | System, x-ray, stationary | 2 | Value Systems |
6 | 60889978621651 | Value Systems | 8621658 | GENERATOR GRP C 50KW 3P 380-480 VAC | KPR | System, x-ray, stationary | 2 | Value Systems |
7 | 60889978615209 | DRX Plus 2530C Detector | 8615205 | DRX PLUS 2530C DETECTOR/ ASCEND | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DRX Plus 2530C Detector |
8 | 60889978611614 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8611618 | 24X30CM DV REPLCMT PLATE/EHR-M2 SCR | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen |
9 | 60889978607587 | 4343R Digital Image Receptor | 8607582 | GOS Scintillator 4343 CM | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | 4343R Digital Image Receptor |
10 | 60889978602773 | DRX-Evolution Plus System | 8602773 | FIBRE GRID DRX-EVO WALL 180CM10:1 40LPCM | KPR | System, x-ray, stationary | 2 | DRX-Evolution Plus System |
11 | 60889978463329 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8463325 | 18X24CM DV REPLCMT PLATE/EHR-M2 SCR | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen |
12 | 60889978359158 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8359150 | 24X30CM DVIEW CR MAMMO SCR EHR-M2 | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen |
13 | 60889978346134 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen | 8346132 | 24X30CM DVIEW CR MAMMO SCR EHR-M | MUE | Full field digital,system,x-ray,mammographic | 2 | DIRECTVIEW CR Mammography Cassette with EHR-M Screen |
14 | 60889978344062 | X-OMAT MX Developer and Replenisher | 8344061 | X-OMAT MX Developer and Repl 10 GL | IWZ | Film, radiographic | 1 | X-OMAT MX Developer and Replenisher |
15 | 60889978215201 | CARESTREAM CR Mammography Cassette with SNP-M1 Screen | 8215204 | 24X30 CR MAMMO CASS W/SNP-M1 SCREEN | MUE | Full field digital,system,x-ray,mammographic | 2 | CARESTREAM CR Mammography Cassette with SNP-M1 Screen |
16 | 60889976701539 | Value Systems | 6701536 | GENERATOR GRP C 65KW 3P 380-480 VAC | KPR | System, x-ray, stationary | 2 | Value Systems |
17 | 60889976701522 | Value Systems | 6701528 | GENERATOR GRP C 80KW 3P 380-480 VAC | KPR | System, x-ray, stationary | 2 | Value Systems |
18 | 60889976701133 | TRIMAX 35C | 6701130 | TRIMAX 35C DETECTOR | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | TRIMAX 35C |
19 | 60889976579367 | Vita Flex CR System | 6579361 | VITA FLEX CR SYSTEM, NB 60PPH WITH PC&MO | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Vita Flex CR System |
20 | 60889976579343 | Vita Flex CR System | 6579346 | VITA FLEX CR SYSTEM 60PPH WITH PC&MONITO | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Vita Flex CR System |
21 | 60889976579336 | Vita Flex CR System | 6579338 | VITA FLEX CR SYSTEM 60PPH | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Vita Flex CR System |
22 | 60889976573785 | LINEAR MC 150 | 6573786 | R40-M-R MANUAL COLLIMATOR FOR DR | IZX | Collimator, manual, radiographic | 2 | LINEAR MC 150 |
23 | 60889976573631 | QW-420-T | 6573638 | QW-420-T MOTORIZED TILT WALL STAND RT | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420-T |
24 | 60889976573624 | QW-420-T | 6573620 | QW-420-T Motor Tilting Wall Stand (Left) | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420-T |
25 | 60889976573594 | QW-420-T | 6573596 | QW-420-MT Manual Tiltng WallStand (Left) | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420-T |
26 | 60889976573587 | QW-420-T | 6573588 | QW-420-MT Manual Tilting Wall Stand RT | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420-T |
27 | 60889976573525 | QT-730 | 6573521 | QT-730 RADIOGRAPHC ENCLOSED STYL TABLE | IZZ | Table, radiographic, non-tilting, powered | 2 | QT-730 |
28 | 60889976573235 | QG-40-3 | 6573232 | QG-400-3 QUEST GEN 32KW 3 PH 380-480 | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | QG-40-3 |
29 | 60889976567876 | CS 3500 3D Scanner Collar | 6567879 | CS3500 COLLAR PACKING (10 PIECES) | NOF | System, optical impression, computer assisted design and manufacturing (cad/cam) System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations | CS 3500 3D Scanner Collar | |
30 | 60889976567166 | LINEAR MC 150 | 1015148 | R40-S-P PINNACLE MTRZD COLLIMATOR | IZX | Collimator, manual, radiographic | 2 | LINEAR MC 150 |
31 | 60889976567159 | LINEAR MC 150 | 1013309 | R40-M-P PROGENY MC150 MANUAL COLLIMATOR | IZX | Collimator, manual, radiographic | 2 | LINEAR MC 150 |
32 | 60889976566732 | CS 3500 3D Scanner Collar | 6566731 | CS3500 COLLAR PACKING (10 PIECES) | NOF | System, optical impression, computer assisted design and manufacturing (cad/cam) System, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations | 2 | CS 3500 3D Scanner Collar |
33 | 60889976559857 | CS 1500 | 6559850 | CS1500 HAND PIECE WIRELESS | EIA | UNIT, OPERATIVE DENTAL | 1 | CS 1500 |
34 | 60889976559819 | CS 1500 | 6559819 | CS1500 INTRA ORAL CAMERA WIRED USB | EIA | UNIT, OPERATIVE DENTAL | 1 | CS 1500 |
35 | 60889976559802 | CS 1500 | 6559801 | CS1500 INTRA ORAL CAMERA WIRELESS | EIA | UNIT, OPERATIVE DENTAL | 1 | CS 1500 |
36 | 60889976041376 | Green X-ray Film WB | 6041370 | 25SH 14X36IN (FLAT) GREEN X-RAY WB | IWZ | Film, radiographic | Green X-ray Film WB | |
37 | 60889975950419 | DRX Plus 2530C Detector | AH9482 | PACKED, DETECTOR, 2530 C | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DRX Plus 2530C Detector |
38 | 60889975313580 | CS 8100 Access | 5313580 | CS 8100 ACCESS | MUH | System,x-ray,extraoral source,digital | 2 | CS 8100 Access |
39 | 60889975303062 | CS 8100 Access | 5303060 | CS 8100 ACCESS 110V 230V | MUH | System,x-ray,extraoral source,digital | 2 | CS 8100 Access |
40 | 60889975285931 | READYMATIC Fixer and Replenisher | 5285937 | READYMATIC FIXER AND REPL, 2X5L | IWZ | Film, radiographic | 1 | READYMATIC Fixer and Replenisher |
41 | 60889975284484 | X-OMAT LE+ Fixer and Replenisher | 5284484 | X-OMAT LE+ FIXER AND REPL 2X20L | IWZ | Film, radiographic | 1 | X-OMAT LE+ Fixer and Replenisher |
42 | 60889975211015 | CEPHALOSTAT | 5211016 | CEPH UPGRADE FOR 9X00 FAMILY | MUH,OAS | System,x-ray,extraoral source,digital,X-ray, tomography, computed, dental | 2 | CEPHALOSTAT |
43 | 60889975154237 | CG797 | 5154232 | SIZE A COLLIMAT. FOR I/O XRAY UNITS | EHD | UNIT, X-RAY, EXTRAORAL WITH TIMER | 2 | CG797 |
44 | 60889974160215 | DETECTOR,PACKED,TRIMAX,4343C | AE4205 | AY-DETECTOR, PACKED, 4343C, TRIMAX | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | TRIMAX 4343C Detector |
45 | 60889974007909 | CS 1600 | 9G1174 | Handpiece, Wired, 1600 | NBL | Laser,fluorescence caries detection | 2 | CS 1600 |
46 | 60889974007473 | 4343R Digital Image Receptor | 9G9998 | 43X43 GOS DETECTOR | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | 4343R Digital Image Receptor |
47 | 60889974007466 | 4343R Digital Image Receptor | 9G5716 | DRX-DETECTOR 43X43 CSI FIXED | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | 4343R Digital Image Receptor |
48 | 60889974001112 | QG-50-SE | 1015247 | QG-5000-4 ODYSSEY SE GEN 50KW | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | QG-50-SE |
49 | 60889974000979 | QG-40-3 | 1023290 | QG-40-3 X-RAY GEN 40KW 3 PHASE 380-480 | IZO | Generator, high-voltage, x-ray, diagnostic | 1 | QG-40-3 |
50 | 60889974000696 | QW-420 | 1018811 | QW-420 VERTI-Q-VERTICAL WALLSTAND LEFT | IXY | Holder, radiographic cassette, wall-mounted | 1 | QW-420 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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 | |
2 | 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 | |
3 | 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 | |
4 | 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 | |
5 | 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 | |
6 | 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 | |
7 | 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 | |
8 | 00616258026428 | CAL-VIEWER | CAL-VIEWER | Calantic Viewer (88439783) | Calantic Viewer | BAYER MEDICAL CARE INC. |
9 | 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 | |
10 | B295VBB60 | 6 | Basic radiologist workstation | ViewBox Basic | RADIUS | |
11 | B295VBA10 | 1 | Advanced radiologist workstation | ViewBox Advanced | RADIUS | |
12 | B295PACSCORE60 | 6 | PACSCore back-end archive | PACSCore | RADIUS | |
13 | B295FULLPACS30 | 3 | ConnectWeb viewer front-end with PACSCore back-end archive | ConnectWeb with PACSCore | RADIUS | |
14 | B295DICOMFWD30 | 3 | Basic DICOM gateway | DicomForward | RADIUS | |
15 | 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. | |
16 | 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. | |
17 | AMBRMOBILEAPP0 | AMBRMOBILEAPP0 | Mobile Application version of Ambra Health. Not intended for diagnostic purposes. | Ambra Health Mobile Application | AMBRA HEALTH | |
18 | 60889978671366 | Vue RIS | 8671364 | RIS SOFTWARE < 25K EXAMS / YEAR | Vue RIS | CARESTREAM HEALTH, INC. |
19 | 60889976574645 | DRX - Ascend System | 6574644 | QG-TV-CM | DRX - Ascend System | CARESTREAM HEALTH, INC. |
20 | 60889976574638 | DRX - Ascend System | 6574636 | QG-TV10-C TECHVISION RS-590 WITH Q-VISIO | DRX - Ascend System | CARESTREAM HEALTH, INC. |
21 | 60889976573341 | QG-TV-IP-FM | 6573349 | QG-TV10-IPF-MAT TECHVISION QS-550 DRX AT | QG-TV-IP-FM | CARESTREAM HEALTH, INC. |
22 | 60889976573341 | QG-TV-IP-FM | 6573349 | QG-TV10-IPF-MAT TECHVISION QS-550 DRX AT | QG-TV-IP-FM | CARESTREAM HEALTH, INC. |
23 | 60889976573334 | QG-TV-IP-F | 6573331 | QG-TV10-IPF TECHVISION QS-550 WITH DRX | QG-TV-IP-F | CARESTREAM HEALTH, INC. |
24 | 60889976573334 | QG-TV-IP-F | 6573331 | QG-TV10-IPF TECHVISION QS-550 WITH DRX | QG-TV-IP-F | CARESTREAM HEALTH, INC. |
25 | 60889976573327 | QG-TV-IP-CM | 6573323 | QG-TV10-IPC-MAT TECHVISION RS-590 DRX AT | QG-TV-IP-CM | CARESTREAM HEALTH, INC. |
26 | 60889976573327 | QG-TV-IP-CM | 6573323 | QG-TV10-IPC-MAT TECHVISION RS-590 DRX AT | QG-TV-IP-CM | CARESTREAM HEALTH, INC. |
27 | 60889976573310 | QG-TV-IP-C | 6573315 | QG-TV10-IPC TECHVISION RS-590 WITH DRX | QG-TV-IP-C | CARESTREAM HEALTH, INC. |
28 | 60889976573310 | QG-TV-IP-C | 6573315 | QG-TV10-IPC TECHVISION RS-590 WITH DRX | QG-TV-IP-C | CARESTREAM HEALTH, INC. |
29 | 60889976573303 | QG-TV-FM | 6573307 | QG-TV10-F-MAT TECHVISION QS-550 Q-VISION | QG-TV-FM | CARESTREAM HEALTH, INC. |
30 | 60889976573297 | QG-TV-F | 6573299 | QG-TV10-F TECHVISION QS-550 WITH Q-VISIO | QG-TV-F | CARESTREAM HEALTH, INC. |
31 | 60889976573235 | QG-40-3 | 6573232 | QG-400-3 QUEST GEN 32KW 3 PH 380-480 | QG-40-3 | CARESTREAM HEALTH, INC. |
32 | 60889976573228 | QG-40-2 | 6573224 | QG-400-2 QUEST GEN 32KW 3 PH 208-240 | QG-40-2 | CARESTREAM HEALTH, INC. |
33 | 60889976573211 | QG-32-3 | 6573216 | QG-320-3 QUEST GEN 32KW 3 PH 380-480 | QG-32-3 | CARESTREAM HEALTH, INC. |
34 | 60889976573204 | QG-32-2 | 6573208 | QG-320-2 QUEST GEN 32KW 3 PH 208-240 | QG-32-2 | CARESTREAM HEALTH, INC. |
35 | 60889976571866 | DRX - Ascend System | 6571863 | TECHVISIN SYSTM,RS-590 WIT | DRX - Ascend System | CARESTREAM HEALTH, INC. |
36 | 60889976571842 | QG-40-SE | 6571848 | QG-400-4 QUEST GEN, 40kW STORED | QG-40-SE | CARESTREAM HEALTH, INC. |
37 | 60889976571835 | QG-40 | 6571830 | QG-400-1 GENERATOR, QUEST,1-PHASE 40KW | QG-40 | CARESTREAM HEALTH, INC. |
38 | 60889976571828 | QG-32-SE | 6571822 | QG-320-4 GENERATOR, QUEST, 32KW STORED | QG-32-SE | CARESTREAM HEALTH, INC. |
39 | 60889976571811 | QG-32 | 6571814 | QG-320-1 GENERATOR, QUEST 1-PHASE 32KW | QG-32 | CARESTREAM HEALTH, INC. |
40 | 60889975950013 | DRX-Revolution Mobile X-ray System | AF5684 | MOBILE X-RAY GENERATOR | DRX-Revolution Mobile X-ray System | CARESTREAM HEALTH, INC. |
41 | 60889974005226 | DRX - Ascend System | 1025907 | TECHVISION FOR CEILING SYSTEM | DRX - Ascend System | CARESTREAM HEALTH, INC. |
42 | 60889974001112 | QG-50-SE | 1015247 | QG-5000-4 ODYSSEY SE GEN 50KW | QG-50-SE | CARESTREAM HEALTH, INC. |
43 | 60889974001006 | QG-50 | 1014125 | QG-5000-3 ODYSSEY GEN 50KW 3 PH 380-480 | QG-50 | CARESTREAM HEALTH, INC. |
44 | 60889974000993 | QG-50 | 1021336 | QG-50 X-RAY GEN 50KW 3 PHASE 380-480 | QG-50 | CARESTREAM HEALTH, INC. |
45 | 60889974000986 | QG-40-SE | 1023308 | QG-40-4 X-RAY SE GEN 40KW | QG-40-SE | CARESTREAM HEALTH, INC. |
46 | 60889974000979 | QG-40-3 | 1023290 | QG-40-3 X-RAY GEN 40KW 3 PHASE 380-480 | QG-40-3 | CARESTREAM HEALTH, INC. |
47 | 60889974000962 | QG-32-SE | 1015239 | QG-3200-4 ODYSSEY SE GEN 32KW | QG-32-SE | CARESTREAM HEALTH, INC. |
48 | 60889974000955 | QG-32-3 | 1015221 | QG-3200-3 ODYSSEY GEN 32KW 3 PH 380-480 | QG-32-3 | CARESTREAM HEALTH, INC. |
49 | 60889974000542 | QG-80 | 1015288 | QGV-80 Q-VISION GEN 80KW | QG-80 | CARESTREAM HEALTH, INC. |
50 | 60889974000535 | QG-65 | 1014133 | QGV-65 Q-VISION GEN 65KW | QG-65 | CARESTREAM HEALTH, INC. |