| 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 | 04961333244331 | SCALE OR | SCALEOR, DVI INPUT, W/OUT FIBER | SCALEOR | PENTAX OF AMERICA, INC. | |
| 2 | 04961333242146 | 90T1009 | DVI FOUR FIBER OUTPUT MODULE | N/A | PENTAX OF AMERICA, INC. | |
| 3 | 04961333242139 | 90T1008 | 3G/HD-SDI/SDI OUTPUT MODULE | N/A | PENTAX OF AMERICA, INC. | |
| 4 | 04961333242122 | 90T1007 | 3G/HD-SDI/SDI INPUT MODULE | N/A | PENTAX OF AMERICA, INC. | |
| 5 | 04961333242115 | 90T1006 | DVI OUTPUT MODULE | N/A | PENTAX OF AMERICA, INC. | |
| 6 | 04961333242108 | 90T1005 | DVI INPUT MODULE | N/A | PENTAX OF AMERICA, INC. | |
| 7 | 04961333242092 | 90T0010 | SCALEOR,DVI INPUT, W/FIBER | N/A | PENTAX OF AMERICA, INC. | |
| 8 | 04548736094406 | UPA-WU10T | Wireless Print Transmitter | SONY | SONY CORPORATION | |
| 9 | 04548736094390 | UPA-WU10R | Wireless Print Receiver | SONY | SONY CORPORATION | |
| 10 | 04548736035874 | UPA-WU10 | Wireless Print System | SONY | SONY CORPORATION | |
| 11 | 04260476510045 | v2 | aycan xray-print | AYCAN DIGITALSYSTEME GMBH | ||
| 12 | EOLEAUTOMATIONV1P01 | 1.0 | The Automation Platform is a software product that transfers, stores, converts f The Automation Platform is a software product that transfers, stores, converts formats, and displays medical device image data. It does not modify the image data or modify the display of the image data. The Automation Platform reads images and interprets DICOM tags, analyzes pixels to identify body part and sequence type in order to categorize the images.The Automation Platform is not intended to be used for active patient monitoring nor primary image interpretation.The Automation Platform allows routing DICOM-compliant image data to and from automated post processing applications, but such processing applications are not a part of the platform itself.Automation Platform allows post processing applications to provide a notification or a flag intended to inform the user. | Automation Platform | OLEA MEDICAL USA | |
| 13 | 04056481144265 | 1.1 | Buzz Virtual App | BRAINLAB AG | ||
| 14 | 04056481143527 | 4.3 | DICOM Proxy | BRAINLAB AG | ||
| 15 | 04056481143305 | 15800A | Buzz 2.0 | BRAINLAB AG | ||
| 16 | 04056481143046 | 15501 | Buzz Virtual | BRAINLAB AG | ||
| 17 | 04056481143039 | 15790 | Buzz Compact | BRAINLAB AG | ||
| 18 | 04056481142810 | 3.1 | 39010 | QUENTRY SUBSCRIPTION | BRAINLAB AG | |
| 19 | 04056481140977 | 15800 | Buzz 2.0 | BRAINLAB AG | ||
| 20 | 04056481140519 | 4.1 | DICOM Proxy | BRAINLAB AG | ||
| 21 | 04056481139049 | 4.0 | 30074-03S | DICOM Proxy 4.0 | BRAINLAB AG | |
| 22 | 04056481138226 | 3.4 | 30074-03O | DICOM Proxy | BRAINLAB AG | |
| 23 | 04056481132224 | 3.4 | 30074-03N | DICOM Proxy | BRAINLAB AG | |
| 24 | 04049539103512 | Model II | CALLISTO eye Panel PC | CARL ZEISS MEDITEC AG | ||
| 25 | 04048551418147 | WM200 | OR1 SmartScreen | SMARTSCREEN | KARL STORZ GMBH & CO. KG | |
| 26 | 03770019599013 | v1.2.0 | inHEART Models Shaper is a medical image processing and visualization software f inHEART Models Shaper is a medical image processing and visualization software for manual 3D segmentation including cardiac images. It provides simple image review software functionality for basic medical image processing and manipulation, such as grayscale window and level, zoom and pan, image reformat, thresholding or user delineated geometric measurements (distance and volume). It is intended to be used by inHEART trained staffs.inHEART Models Shaper is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians).Clinicians are solely responsible for making all final patient management decisions. | inHEART Models Shaper | INHEART | |
| 27 | 03770019599006 | v2.2.1 | inHEART Models Explorer is a web-based visualization software for display, revie inHEART Models Explorer is a web-based visualization software for display, review, annotation and export of digital 3D models segmented from medical images including cardiac images (CT and/or MR). It is intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians), as well as by inHEART trained staffs.inHEART Models Explorer is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians).Clinicians are solely responsible for making all final patient management decisions. | inHEART Models Explorer | INHEART | |
| 28 | 00866389000129 | C-Arm Kit | The Radlink Wireless C-Arm (WCA) Kit is an accessory device of the Radlink GPS ( The Radlink Wireless C-Arm (WCA) Kit is an accessory device of the Radlink GPS (Galileo Positioning System) & GPS Tablet that is used to wirelessly send images from a video source such as a C-Arm to the Radlink GPS or GPS Tablet. The Radlink Wireless C-Arm Kit is a computer system that accepts video signals from BNC, VGA, or DVI connections and converts these signals into an image file, which is then sent wirelessly to a Radlink GPS or GPS Tablet. | Radlink Wireless C-Arm Kit | RADLINK, INC. | |
| 29 | 00865885000220 | ShowCase Viewer for iPad | ShowCase Viewer for iPad is a DICOM medical image viewer for the Apple iPad. Sho ShowCase Viewer for iPad is a DICOM medical image viewer for the Apple iPad. ShowCase Viewer for iPad is not intended for diagnostic use. | SHOWCASE® | TRILLIUM TECHNOLOGY, INC. | |
| 30 | 00860006066307 | MS-100-1001 | MediScout® is an augmented reality accessory to clinical ultrasound (US) systems MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration. | MediScout system | MEDIVIEW XR, INC. | |
| 31 | 00860002800301 | 01 | Apollo arcc® is a Health Information System facilitating the combination of pati Apollo arcc® is a Health Information System facilitating the combination of patient information received from another information system (HL7 interface) with clinical multimedia (images, video, audio and other formats) and clinical information in a highly organized and secure environment. Patient information may also be entered directly into arcc. The workflow is representative of standard clinical specialties including but not limited to pathology, gastroenterology, dermatology, surgery, etc. Digital media can be imported via TCP/IP or via digital capture through direct connection to a modality device (Ex. would be a microscope mounted camera). | arcc | APOLLO ENTERPRISE IMAGING CORP | |
| 32 | 00860002304540 | 1.0.0 | Software that provides standardized metadata descriptions of diagnostic medical Software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language processing and computer vision algorithms to analyze DICOM images and metadata to identify key attributes of radiological examinations and series. | Curie ENDEX | ENLITIC, INC. | |
| 33 | 00860002304533 | 1.0.0 | Standardize is software that provides standardized metadata descriptions of diag Standardize is software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language processing and computer vision algorithms to analyze DICOM images and metadata to identify key attributes of radiological examinations and series. | Standardize | ENLITIC, INC. | |
| 34 | 00860002304526 | 1.0.0 | The Curie product is a software platform that hosts applications related to vari The Curie product is a software platform that hosts applications related to various healthcare workflows, contains basic functionality such as user access and security, and allows for integrations with other devices such as third-party PACs systems. | Enlitic Curie | ENLITIC, INC. | |
| 35 | 00860001554533 | DOCS | DOCS system is an audio/video integration system that is installed in health car DOCS system is an audio/video integration system that is installed in health care facilities where video-assisted procedures are performed. The DOCS system is used by trained health care personnel to route video signals from medical equipment (i.e., endoscopic cameras, C-arms, ultrasound, PACS) to flat-panel monitors for display during procedures. | DOCS | CV MEDICAL, LLC | |
| 36 | 00860001554526 | U | The NuBOOM/DOCS system is an equipment management and audio/video integration sy The NuBOOM/DOCS system is an equipment management and audio/video integration system that is installed in health care facilities where video-assisted procedures are performed. The NuBOOM/DOCS system is used by trained health care personnel to route video signals from medical equipment (i.e., endoscopic cameras, C-arms, ultrasound, PACS) to flat-panel monitors for display during procedures.The NuBOOM/DOCS system consists of two major components: an equipment management subsystem and a video integration subsystem.The equipment management subsystem—called the NuBOOM—is a metal superstructure (cabinet) that is anchored to the facility floor. The cabinet provides an attachment point for booms, which support adjustable arms with flat-panel monitors, and shelves for storage of medical equipment. The booms and spring arms can be moved to allow the most ergonomic placement of the flat-panel monitors. The equipment management component of the NuBOOM/DOCS system provides health care staff with an adjustable system that can be configured to the needs of each procedure. | NuBOOM | CV MEDICAL, LLC | |
| 37 | 00860001554519 | NuCART | The NuCART® is a mobile display and image management platform intended to be use The NuCART® is a mobile display and image management platform intended to be used by health care providersin Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signalsfrom source devices to monitors. It is tailored for use with a C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites. | NuCART | CV MEDICAL, LLC | |
| 38 | 00860001554502 | NuVIEW | The NuVIEW® is a mobile visualization platform tailored for use with a C-arm and The NuVIEW® is a mobile visualization platform tailored for use with a C-arm and Patient Monitor in Minimally Invasive Surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites. Designed for mobility and simplicity it will compete with entry level mobile carts. The NuVIEW® product is comprised of Mechanical and Hardware design inputs. | NuVEIW | CV MEDICAL, LLC | |
| 39 | 00859873006066 | 2 | The GOLD™ Lx is a client-server distribution image storage and communication sys The GOLD™ Lx is a client-server distribution image storage and communication system whose intended use is to provide solutions for hospital and related institutions/sites, which will store, retrieve, and distribute medical images and data from vendor modalities and hospital information systems. | GOLDLx | HERMES MEDICAL SOLUTIONS AB | |
| 40 | 00859873006011 | 1.6 | The GOLD™ Lx is a client-server distribution image storage and communication sys The GOLD™ Lx is a client-server distribution image storage and communication system whose intended use is to provide solutions for hospital and related institutions/sites, which will store, retrieve, and distribute medical images and data from vendor modalities and hospital information systems. | GOLD Lx | HERMES MEDICAL SOLUTIONS AB | |
| 41 | 00859151005255 | MVR400Z | MVR400Z | MediCap | MEDICAPTURE, INC. | |
| 42 | 00859151005170 | MVR408 | MVR408 | MVR | MEDICAPTURE, INC. | |
| 43 | 00859151005156 | MVC410 | MVC410 - MVC Pro SDI to HDMI Converter | MVC | MEDICAPTURE, INC. | |
| 44 | 00859151005132 | MVR420 | MVR420 | MVR | MEDICAPTURE, INC. | |
| 45 | 00859151005101 | MVR409 | MVR409 | MVR | MEDICAPTURE, INC. | |
| 46 | 00859151005033 | MVR400 | MVR400 | MVR | MEDICAPTURE, INC. | |
| 47 | 00859151005026 | USB170 | USB170 | MediCap | MEDICAPTURE, INC. | |
| 48 | 00859151005019 | USB300 | USB300 | MediCap | MEDICAPTURE, INC. | |
| 49 | 00859151005002 | USB200 | USB200 | MediCap | MEDICAPTURE, INC. | |
| 50 | 00858012005977 | 9.1 | PowerLook | ICAD, INC. |