| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00854344007283 | v4.0.1 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Varex Imaging, Nexus DR Digital Imaging Software | ||
| 2 | 00854344007184 | Nexus, DR, v3.2 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Varex Digital Imaging Software, Nexus, DR, v3.2 | ||
| 3 | 00854344007115 | Precision MPi DSA | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | InfiMed Digital Imaging System, Precision MPi, DSA, CCD Camera | ||
| 4 | 00854344007078 | Nexus DRF (RF/DR) | OWB,MQB,JAA | Interventional Fluoroscopic X-Ray System,Solid State X-Ray Imager (Flat Panel/Di Interventional Fluoroscopic X-Ray System,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic, Image-Intensified | 2 | InfiMed Digital Imaging System, Nexus, RF/DR, Non Varian Digital Receptor | ||
| 5 | 00854344007269 | v3.0.0 | MQB,JAA | Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Varex Imaging Nexus DRF Imaging Software | ||
| 6 | 00854344007658 | v4.9 | Digital image acquisition system designed to automate patient work flow that inc Digital image acquisition system designed to automate patient work flow that includes image processing algorithms for imaging. | JAA,MQB | System, X-Ray, Fluoroscopic, Image-Intensified,Solid State X-Ray Imager (Flat Pa System, X-Ray, Fluoroscopic, Image-Intensified,Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Varex Digital Imaging Software, Nexus DR | |
| 7 | 00854344007405 | Nexus DR v4.2.0 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Digital Imaging System, Nexus DR, v4.2.0 | ||
| 8 | 00854344007016 | Nexus, DR, v3.1 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Varex Digital Imaging Software, Nexus, DR, v3.1 | ||
| 9 | 00854344007443 | Nexus DRF v3.2.0 | MQB,JAA | Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Varex Digital Imaging System, Nexus, DRF, v3.2.0 | ||
| 10 | 00854344007221 | Nexus DR v4.1.0 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Varex Digital Imaging System, Nexus DR v4.1.0 | ||
| 11 | 00854344007085 | Platinum One RF | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | InfiMed Digital Imaging System, Platinum One, RF, CCD Camera | ||
| 12 | 00854344007009 | i5 DSA | OWB,MQB,JAA,IZI | Interventional Fluoroscopic X-Ray System,Solid State X-Ray Imager (Flat Panel/Di Interventional Fluoroscopic X-Ray System,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic, Image-Intensified,System, X-Ray, Angiographic | 2 | InfiMed Digital Imaging System, i5, DSA, CCD Camera | ||
| 13 | 00854344007429 | Nexus DRF v3.1.0 | MQB,JAA | Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Varex Digital Imaging System, Nexus, DRF, v3.1.0 | ||
| 14 | 00854344007290 | v4.0.1 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Varex Imaging Nexus DR Digital Imaging System | ||
| 15 | 00854344007054 | Nexus-DRF | MQB,JAA | Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Varex Digital Imaging System, Nexus, RF/DR, Digital Receptor | ||
| 16 | 00854344007047 | i5 DR | OWB,MQB,JAA,IZI | Interventional Fluoroscopic X-Ray System,Solid State X-Ray Imager (Flat Panel/Di Interventional Fluoroscopic X-Ray System,Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic, Image-Intensified,System, X-Ray, Angiographic | 2 | InfiMed Digital Imaging System, i5, DR, Digital Receptor | ||
| 17 | 00854344007559 | Diagnostic X-Ray Tube VRX-RAD | Diagnostic X-Ray RAD Tube | ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | Varex Imaging | |
| 18 | 00854344007542 | Diagnostic X-Ray Tube VRX-Mammo | Diagnostic X-Ray Mammo Tube | ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | Varex Imaging | |
| 19 | 00854344007535 | Diagnostic X-Ray Tube VRX-CT | Diagnostic X-Ray CT Tube | ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | Varex Imaging | |
| 20 | 00854344007276 | v3.0.0 | MQB,JAA | Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Varex Imaging Nexus DRF Digital X-ray Imaging System | ||
| 21 | 00854344007108 | Precision MPi RF | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | InfiMed Digital Imaging System, Precision MPi, RF, CCD Camera | ||
| 22 | 00854344007436 | Nexus DR v4.5.0 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Nexus DR v4.5.0 Digital Imaging System | ||
| 23 | 00854344007092 | Precision RXi D | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | InfiMed Digital Imaging System, Precision RXi, RF/DSA, CCD Camera | ||
| 24 | 00854344007023 | Nexus, DRF, v2.5 | JAA,MQB | System, X-Ray, Fluoroscopic, Image-Intensified,Solid State X-Ray Imager (Flat Pa System, X-Ray, Fluoroscopic, Image-Intensified,Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Varex Digital Imaging Software, Nexus, DRF, v2.5 | ||
| 25 | 00854344007474 | v3.1.2 | Nexus DRF v3.1.2 | JAA,MQB | System, X-Ray, Fluoroscopic, Image-Intensified,Solid State X-Ray Imager (Flat Pa System, X-Ray, Fluoroscopic, Image-Intensified,Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Nexus DRF, Digital Imaging Software | |
| 26 | 00854344007245 | v3.1.1 | MQB,JAA | Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic Solid State X-Ray Imager (Flat Panel/Digital Imager),System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Nexus DRF, Digital Imaging Software | ||
| 27 | 00854344007122 | Platinum One DSA | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | InfiMed Digital Imaging System, Platinum One, DSA, CCD Camera | ||
| 28 | 00854344007030 | Nexus DR | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Varex Digital Imaging System, Nexus, DR, Digital Receptor |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 20193489066927 | 80400839 | 80400839 | CONTRAST CONT ELONG SPIKE ASSY-OEM | NAMIC | MEDLINE INDUSTRIES, INC. |
| 2 | 19120075320075 | 1 | P04-2 | Loop-X Mobile Imaging Robot:Mobile (within an imaging facility) assembly of diag Loop-X Mobile Imaging Robot:Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications. | Loop-X | MEDPHOTON GMBH |
| 3 | 19120075320068 | 1 | Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomogr Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications. | ImagingRing m | MEDPHOTON GMBH | |
| 4 | 18130400103533 | VS3-IR | 115-0012 | Pack of 10 Drapes for VS3 Iridium Fluorescence (MMS-IR) | VISIONSENSE LTD. | |
| 5 | 16280119411015 | 1 | 101 | The flat panel detector, when used with a radiographic imaging system, is intend The flat panel detector, when used with a radiographic imaging system, is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes. | Reveal 35C | KA IMAGING INC |
| 6 | 15420045505896 | InSight 2 | InSight 2 | HOLOGIC, INC. | ||
| 7 | 14522281500886 | 622365 | 622365 | FCS1200 FLUID COLLECTION SYSTEM | NA | B. BRAUN MEDICAL INC. |
| 8 | 10858701006213 | SK6000 | SK6000 | SPY2000 drug and drape kit | SPY | NOVADAQ TECHNOLOGIES INC |
| 9 | 10815411020298 | GMR40 | GMR40 Retrofit Kit | NEUROLOGICA CORP. | ||
| 10 | 10813040013681 | VS3-IR | 115-0011 | Pack of 10 Drapes for VS3 Iridium Fluorescence (MMS-IR) | VISIONSENSE LTD. | |
| 11 | 10746190002826 | 705560 | HYDRA VISION DIGITAL IMAGING SYSTEM, 80KW SYSTEM | LF | LIEBEL-FLARSHEIM COMPANY LLC | |
| 12 | 10746190002819 | 705559 | HYDRA VISION DIGITAL IMAGING SYSTEM, 65KW SYSTEM | LF | LIEBEL-FLARSHEIM COMPANY LLC | |
| 13 | 10746190002475 | 700560 | Direct Digital Urology Imaging System, 80 kW | LF | LIEBEL-FLARSHEIM COMPANY LLC | |
| 14 | 10746190002468 | 700559 | Direct Digital Urology Imaging System, 64kW | LF | LIEBEL-FLARSHEIM COMPANY LLC | |
| 15 | 10193489059458 | 64046007 | 64046007 | MTO BAG CONTRAST BOTTLE HANGER 50CC PG | NAMIC | MEDLINE INDUSTRIES, INC. |
| 16 | 10193489059038 | 64000955 | 64000955 | PROTECTION STATION PLUS W/CMS PG | NAMIC | MEDLINE INDUSTRIES, INC. |
| 17 | 10193489058833 | 64000090 | 64000090 | CONTRAST CONT.SPIKE ASM CHAMBER PG | NAMIC | MEDLINE INDUSTRIES, INC. |
| 18 | 10193489058826 | 64000010 | 64000010 | CUST.SPEC.PRD-CHECK VALVE CMS PG | NAMIC | MEDLINE INDUSTRIES, INC. |
| 19 | 09357123000013 | Rover | MXU-RV19 | The device is designed to perform radiographic x-ray examinations on pediatric a The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas | Micro-X | MICRO-X LIMITED |
| 20 | 08904269405519 | F303-000187-2 | SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervention surgical procedures. The device can also be used for radiographic applications. | Skan C Mobile C - Arm X - Ray system | SKANRAY TECHNOLOGIES LIMITED | |
| 21 | 08904269403683 | 303-000018-16 | SKANMOBILE DR is a digital radiographic system designed for superior image quali SKANMOBILE DR is a digital radiographic system designed for superior image quality featuring wireless flat panel detectorand operator console for digital imaging integrated with high frequency generator. | SKANMOBILE DR | SKANRAY TECHNOLOGIES LIMITED | |
| 22 | 08809466040511 | FR31 | CG-301 | The FireCR Spark System is ideal for Computed Radiography examinations in busy c The FireCR Spark System is ideal for Computed Radiography examinations in busy clinics and specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR Spark System enables all imaging functions to be performed with the advanced image management software, a solution that can be adapted most clinical applications. | FireCR Spark | DIGIRAY CORP. |
| 23 | 08809466040443 | CA06 | The Cassette 18cmx24cm(IP 18cmx24cm)Kit is acquired X-ray images. and Transfer t The Cassette 18cmx24cm(IP 18cmx24cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash. | Cassette 18cmx24cm(IP 18cmx24cm)Kit | DIGIRAY CORP. | |
| 24 | 08809466040436 | CA05 | The Cassette 24cmx30cm(IP 24cmx30cm)Kit is acquired X-ray images. and Transfer t The Cassette 24cmx30cm(IP 24cmx30cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash. | Cassette 24cmx30cm(IP 24cmx30cm)Kit | DIGIRAY CORP. | |
| 25 | 08809466040429 | CA04 | The Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer t The Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR Flash. | Cassette 35cmx43cm(IP 35cmx43cm)Kit | DIGIRAY CORP. | |
| 26 | 08809466040412 | FR41 | CG-401 | The FireCR Flash can be configured for nearly every clinical application, and is The FireCR Flash can be configured for nearly every clinical application, and is designed for full DICOM connectivity, and allows user to setup the system to capture high quality X-ray images of any body parts with minimal steps including reading, processing, displaying and sending of the high quality image. All imaging parameters are optimized, resulting in digital images that can be enhanced, enlarged, duplicated, and sent to any location as a DICOM 3.0 file format in seconds with no loss of resolution. | FireCR Flash | DIGIRAY CORP. |
| 27 | 08809466040313 | FR31 | CG-301 | The FireCR Spark System is ideal for Computed Radiography examinations in busy c The FireCR Spark System is ideal for Computed Radiography examinations in busy clinics and specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR Spark System enables all imaging functions to be performed with the advanced image management software, a solution that can be adapted most clinical applications. | FireCR Spark | DIGIRAY CORP. |
| 28 | 08809466040030 | CA02 | The Universal Cassette 24cmx30cm(IP 24cmx30cm)Kit is acquired X-ray images. and The Universal Cassette 24cmx30cm(IP 24cmx30cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR. | Universal Cassette 24cmx30cm(IP 24cmx30cm)Kit | DIGIRAY CORP. | |
| 29 | 08809466040023 | CA01 | The Universal Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and The Universal Cassette 35cmx43cm(IP 35cmx43cm)Kit is acquired X-ray images. and Transfer the image to your computer through the FireCR. | Universal Cassette 35cmx43cm(IP 35cmx43cm)Kit | DIGIRAY CORP. | |
| 30 | 08809466040016 | FR01 | CG-701 | The FireCR System is ideal for Computed Radiography examinations in busy clinics The FireCR System is ideal for Computed Radiography examinations in busy clinics and specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR System enables all imaging functions to be performed with the advanced image management software, a solution that can be adapted most clinical applications. | FireCR | DIGIRAY CORP. |
| 31 | 08809460309867 | IOX2 | IOX2 | Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digit Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays. | Intra Oral Sensor | DENTIUM CO., LTD |
| 32 | 08809460309850 | IOX1 | IOX1 | Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digit Intra Oral Sensor (model: IOX 1 / IOX 2) is a medical device that acquires digital images by detecting subject information through X-rays. | Intra Oral Sensor | DENTIUM CO., LTD |
| 33 | 08809413810013 | ClearVision ExamVue Flat Panel Detector | The ClearVision ExamVue Flat Panel Detector consists of a line of 3 different mo The ClearVision ExamVue Flat Panel Detector consists of a line of 3 different models of solid state x-ray detectors, of differing size and characteristics, designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. The ClearVision ExamVue Flat Panel Detector captures digital images of anatomy through the conversion of x-rays to electronic signals, eliminating the need for film or chemical processing to create a hard copy image. The ClearVision ExamVue Flat Panel Detector incorporates the ExamVueDR software, which performs the processing, presentation and storage of the image in DICOM format. All models of the ClearVision ExamVue Flat Panel Detector use aSi TFTD for the collection of light generated by a CsI scintillator, for the purpose of creating a digital x-ray image. The three available models are:a. A 14x17in (35x43cm) tethered cassette sized panelb. A 14x17in (35x43cm) wireless cassette sized panel with automatic exposure detectionc. A 17x17in (43x43cm) tethered panel for fixed installations. | ClearVision ExamVue Flat Panel Detector | JPI HEALTHCARE. CO., LTD. | |
| 34 | 08809394330340 | FXRD-4343VAW PLUS | Flat Panel Detector, wireless43cm by 43 cm of size | VIVIX-S 4343VAW PLUS | VIEWORKS CO., LTD. | |
| 35 | 08809394330333 | FXRD-4343VAW | Flat Panel Detector, wireless43cm by 43cm of size | VIVIX-S 4343VAW | VIEWORKS CO., LTD. | |
| 36 | 08809394330326 | FXRD-3643VAW PLUS | Flat Panel Detector, wireless36cm by 43 cm of size | VIVIX-S 3643VAW PLUS | VIEWORKS CO., LTD. | |
| 37 | 08809394330319 | FXRD-3643VAW | Flat Panel Detector, wireless36cm by 43 cm of size | VIVIX-S 3643VAW | VIEWORKS CO., LTD. | |
| 38 | 08809394330302 | FXRD-2530VAW PLUS | Flat Panel Detector, wireless25cm by 30 cm of size | VIVIX-S 2530VAW PLUS | VIEWORKS CO., LTD. | |
| 39 | 08809394330296 | FXRD-2530VAW | Flat Panel Detector of 25 cm by 30 cm size. Wireless | VIVIX-S 2530VAW | VIEWORKS CO., LTD. | |
| 40 | 08809394330289 | FXRD-1751SB | Solid State X-ray Imager (Flat Panel/Digital Imager) | VIVIX-S 1751S | VIEWORKS CO., LTD. | |
| 41 | 08809394330258 | FXRD-1717VA | Solid State X-ray Imager (flat panel/digital imager) | VIVIX-S 1717V | VIEWORKS CO., LTD. | |
| 42 | 08809394330241 | FXRD-1717VA | Solid State X-ray Imager (Flat panel/ digital imager) | VIVIX-S 1717V | VIEWORKS CO., LTD. | |
| 43 | 08809394330234 | FXRD-1417NBW | VIVIX-S 1417N | VIEWORKS CO., LTD. | ||
| 44 | 08809394330227 | FXRD-1417NAW | VIVIX-S 1417N | VIEWORKS CO., LTD. | ||
| 45 | 08809394330210 | FXRD-1717NBW | FXRD-1717N | VIEWORKS CO., LTD. | ||
| 46 | 08809394330203 | FXRD-1717NAW | FXRD-1717N | VIEWORKS CO., LTD. | ||
| 47 | 08809394330197 | FXRD-1717NB | FXRD-1717N | VIEWORKS CO., LTD. | ||
| 48 | 08809394330180 | FXRD-1717NA | FXRD-1717N | VIEWORKS CO., LTD. | ||
| 49 | 08809394330173 | FXRD-1012NBW | FXRD-1012N | VIEWORKS CO., LTD. | ||
| 50 | 08809394330166 | FXRD-1012NAW | FXRD-1012N | VIEWORKS CO., LTD. |