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 | 10628634297015 | 0601 | CloudVue is a software application that allows for the display of medical image CloudVue is a software application that allows for the display of medical image data within a web browser without installing client software. Conceptually, the application comprises two components: the web viewer and the web server. The server is installed on any computer that meets the minimum system requirements and is configured to communicate with a DICOM archive. The server is capable of DICOM and DICOMweb communication, which allows the connected DICOM archive to exist on a physical server or in the cloud, giving institutions the flexibility to choose a system infrastructure that is best suited to their needs. CloudVue provides fast and secure access to full-fidelity CR, CT, DX, HC, IVUS, MR, NM, OP, OPT, OT, PT, SC, US, and XA images using Chrome, Safari, Firefox, or Edge web browsers. With interactive features, such as: multi-study viewing, multi-monitor support, customized screen and tool layouts, annotation saving and loading, measurement drawing and calibration, reference lines, key images, multi-planar reformatting (MPR), MIP, VR rendering, and image link sharing, CloudVue is a feature-rich solution that informs diagnostic decision-making by healthcare professionals. CloudVue also supports these same features across the following devices: Windows 10 and higher, macOS X and higher, iPad Pro 2nd generation and higher, and iPad Air 3 and higher. This level of portability allows healthcare professionals to access their medical image data anytime, anywhere. | CloudVue | INTERNATIONAL MEDICAL SOLUTIONS INC | |
2 | 10627843712777 | 2.x.y | densitas® densityai™ 2.6.4 | densitas® densityai™ | DENSITAS INCORPORATED | |
3 | 10627843712760 | 2.x.y | densitasdensity 2.4.1 | densitasdensity | DENSITAS INCORPORATED | |
4 | 10627843712753 | 2.1.0b | DM-Density | DENSITAS INCORPORATED | ||
5 | 10603295551287 | 451580053 | 451580053 | Cuptimize for Windows | CUPTIMIZE | DEPUY ORTHOPAEDICS, INC. |
6 | 10603295551270 | 451580054 | 451580054 | Cuptimize for Ios | CUPTIMIZE | DEPUY ORTHOPAEDICS, INC. |
7 | 10603295532040 | 451580052 | 451580052 | VELYS Hip Navigation for iOS | VELYS Hip Navigation | DEPUY ORTHOPAEDICS, INC. |
8 | 10603295522850 | 451580051 | 451580051 | VELYS Hip Navigation for Windows | VELYS Hip Navigation | DEPUY ORTHOPAEDICS, INC. |
9 | 09421904268319 | 4.0 | Volpara Density Map 4.0 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
10 | 09421904268289 | 3.4.2 | Volpara Density Map 3.4.2 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
11 | 09421904268258 | 3.4.2 | VolparaDensity 3.4.2 | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
12 | 09421904268241 | 4.0 | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | ||
13 | 09421904268166 | 3.4.1 | VolparaDensity 3.4.1 (Volpara Imaging Software 1.5.5.1) | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
14 | 09421904268128 | 3.3 | Volpara Density Map 3.3 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
15 | 09421904268098 | 3.3 | VolparaDensity 3.3 (Volpara Imaging Software 1.5.3 and 1.5.4) | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
16 | 09421904268050 | 3.2 | Volpara Density Map 3.2 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
17 | 09421904268029 | 3.2 | VolparaDensity 3.2 (Volpara Imaging Software 1.5.2) | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
18 | 09358140000024 | 1.2 | SCI0001 | Quicktome | OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T) | |
19 | 09358140000017 | 1.1 | SCI0001 | Quicktome | OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T) | |
20 | 09351327000848 | 1.2 | 1200-0000 | OPSInsight™ is intended for use as preoperative surgical planning software to ai OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty. | OPSInsight™ | OPTIMIZED ORTHO PTY LTD |
21 | 09351327000091 | 1250-1300 | OPS Plan V.2.0 | Optimized Positioning System (OPS) Plan | OPTIMIZED ORTHO PTY LTD | |
22 | 09351327000077 | 1250-1300 | OPS Plan | Optimized Positioning System (OPS) Plan | OPTIMIZED ORTHO PTY LTD | |
23 | 09120105730464 | V2.11 | The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric meas The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices. | KOALA | IB LAB GMBH | |
24 | 09120105730037 | V2.05 | The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric meas The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features of osteoarthritis (OA) on posterior-anterior or anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease. Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices. | KOALA | IB LAB GMBH | |
25 | 08908008302008 | RADSpa RIS-PACS 4.0 | RADSpa RIS-PACS | RADSpa® | TELERAD TECH PRIVATE LIMITED | |
26 | 08809466041112 | 1.2.1.466 | QuantorView is an image viewing software dedicated DICOM images produced by imag QuantorView is an image viewing software dedicated DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). QuantorView is a high quality viewing software responsible for displaying PACS image data. It enables physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for researching, teaching, teleconferencing and online collaboration. | QuantorView | DIGIRAY CORP. | |
27 | 08809413810471 | ExamVue PACS | The ExamVue PACS is a software solution for the storage, sharing, display and vi The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database. | Box for ExamVue PACS(outside 265mmx185mmx150mm) | JPI HEALTHCARE. CO., LTD. | |
28 | 08809413810174 | ExamVue PACS | The ExamVue PACS is a software solution for the storage, sharing, display and vi The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database. | ExamVue | JPI HEALTHCARE. CO., LTD. | |
29 | 08809278790307 | Xelis Dental 2.0 | Xelis Dental 2.0 | INFINITT HEALTHCARE CO.,LTD. | ||
30 | 08809278790192 | INFINITT RT PACS | INFINITT RT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
31 | 08809278790130 | INFINITT PACS 7.0 | INFINITT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
32 | 08809278790123 | INFINITT ULite | INFINITT ULite | INFINITT HEALTHCARE CO.,LTD. | ||
33 | 08809278790116 | Xelis Dental | Xelis Dental | INFINITT HEALTHCARE CO.,LTD. | ||
34 | 08809278790109 | Xelis Cardiac | Xelis Cardiac | INFINITT HEALTHCARE CO.,LTD. | ||
35 | 08809278790093 | Xelis Fusion | Xelis Fusion | INFINITT HEALTHCARE CO.,LTD. | ||
36 | 08809278790086 | Xelis 3D | Xelis 3D | INFINITT HEALTHCARE CO.,LTD. | ||
37 | 08809278790079 | Xelis | Xelis | INFINITT HEALTHCARE CO.,LTD. | ||
38 | 08809278790062 | INFINITT Cardiology PACS | INFINITT Cardiology PACS | INFINITT HEALTHCARE CO.,LTD. | ||
39 | 08809278790055 | INFINITT PACS | INFINITT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
40 | 08809278790000 | STARPACS | STARPACS | INFINITT HEALTHCARE CO.,LTD. | ||
41 | 08806167789466 | USO-U0N5B0K/WR | 5D Viewer | SAMSUNG MEDISON CO., LTD. | ||
42 | 08806167761172 | USO-U0N5B0B/WR | 5D VIEWER | SAMSUNG MEDISON CO., LTD. | ||
43 | 08800086200064 | V-B-pAb-02 | Veuron-Brain-pAb2 | HEURON CO.,LTD. | ||
44 | 08800086200026 | V-B-pAb-01 | Veuron-Brain-pAb | HEURON CO.,LTD. | ||
45 | 08800086200019 | V-B-mN1-01 | Veuron-Brain-mN1 | HEURON CO.,LTD. | ||
46 | 08800046800006 | 1.1.0 | ClariCT.AI | CLARIPI INC. | ||
47 | 08800025300084 | 1.1 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
48 | 08800025300077 | 1.1 | AVIEW | CORELINE SOFT CO.,LTD. | ||
49 | 08800025300039 | 1.0 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
50 | 08800025300022 | 1.1 | AVIEW Modeler | CORELINE SOFT CO.,LTD. |