No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00840682145978 | GCMWS-C5 | IXY | Holder, radiographic cassette, wall-mounted | 1 | NA | ||
2 | 00840682140942 | 5765282 | IZZ | Table, radiographic, non-tilting, powered | 2 | NA | ||
3 | 00840682146555 | 5835165 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | NA | ||
4 | 00840682141932 | 6788888-2 | IXQ,IZZ | Table, radiographic, stationary top,Table, radiographic, non-tilting, powered | 2 | NA | ||
5 | 00840682141895 | 5786623 | IZZ | Table, radiographic, non-tilting, powered | 2 | NA | ||
6 | 00840682138932 | 5794807 | CCX | SUPPORT, PATIENT POSITION | 1 | NA | ||
7 | 00840682138925 | B2100BLT | CCX | SUPPORT, PATIENT POSITION | 1 | NA | ||
8 | 00840682125871 | 5896002 | IXY | Holder, radiographic cassette, wall-mounted | 1 | NA | ||
9 | 00840682125864 | 9999966 | IXQ | Table, radiographic, stationary top | 2 | NA | ||
10 | 00840682125857 | 5896000 | IXY | Holder, radiographic cassette, wall-mounted | 1 | NA | ||
11 | 00840682123839 | 6788888 | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | NA | ||
12 | 00840682118583 | EXPRESS COIL - POSTERIOR ARRAY | LNI,LNH | System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resona System, nuclear magnetic resonance spectroscopic,System, nuclear magnetic resonance imaging | 2 | NA | ||
13 | 00840682118033 | 5455274-100 | G8336LL | LNH | System, nuclear magnetic resonance imaging | 2 | NA | |
14 | 00840682117906 | 6999999 | IZZ | Table, radiographic, non-tilting, powered | 2 | NA | ||
15 | 00840682116794 | 54576659-100 | LNH | System, nuclear magnetic resonance imaging | 2 | NA | ||
16 | 00840682106504 | 4265300 | MOS,LNH | Coil, magnetic resonance, specialty,System, nuclear magnetic resonance imaging | 2 | NA | ||
17 | 00840682103572 | 5121647-4 | IZZ | Table, radiographic, non-tilting, powered | 2 | NA | ||
18 | 00840682102674 | 5380966 | IZZ | Table, radiographic, non-tilting, powered | 2 | NA | ||
19 | 00195278569813 | 5135678-9 | BB X-RAY OVERHEAD TUBE SUSPENSION | IYB | Tube mount, x-ray, diagnostic | 1 | NA | |
20 | 00195278569745 | 5135678-10 | BB X-RAY OVERHEAD TUBE SUSPENSION | IYB | Tube mount, x-ray, diagnostic | 1 | NA | |
21 | 00195278527455 | 9999666 | 9999666 | Bamboo RAD Elevation Table | IZZ | Table, radiographic, non-tilting, powered | 2 | NA |
22 | 00195278363947 | 1.0 | MaxFOV 2 Application Container for Smart Subscription | JAK | System, x-ray, tomography, computed | 2 | MaxFOV 2 | |
23 | 00195278012258 | 6788888-3 | G4 Table HLA | IZZ | Table, radiographic, non-tilting, powered | 2 | NA | |
24 | 00195278011022 | 5842636 | G4 Non-Tilting Wallstand | IXY | Holder, radiographic cassette, wall-mounted | 1 | NA | |
25 | 00840682117869 | 5376496-15 | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | Brivo 615 | ||
26 | 00840682154338 | H2401DS | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | D630 to D670 DR Upgrade | ||
27 | 00840682120777 | XRa | PDU COMPONENT ASSEMBLE | KPR | System, x-ray, stationary | 2 | Proteus | |
28 | 00840682145541 | One CFD | OWB,JAA,OXO | Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-inte Interventional fluoroscopic x-ray system,System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x-ray system, mobile | 2 | OEC | ||
29 | 00840682147392 | Maxima US | Revolution Maxima CT designated medical device, WSO make | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
30 | 00840682146197 | ACT LMB | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
31 | 00840682146180 | Maxima | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
32 | 00840682146159 | Ace | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
33 | 00840682137553 | Frontier | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
34 | 00840682135313 | ACT | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
35 | 00840682125604 | One | OWB,OXO,JAA | Interventional fluoroscopic x-ray system,Image-intensified fluoroscopic x-ray sy Interventional fluoroscopic x-ray system,Image-intensified fluoroscopic x-ray system, mobile,System, x-ray, fluoroscopic, image-intensified | 2 | OEC | ||
36 | 00840682118835 | Elite MiniView | OXO,JAA | Image-intensified fluoroscopic x-ray system, mobile,System, x-ray, fluoroscopic, Image-intensified fluoroscopic x-ray system, mobile,System, x-ray, fluoroscopic, image-intensified | 2 | OEC | ||
37 | 00840682115438 | Brivo Essential | OXO,JAA | Image-intensified fluoroscopic x-ray system, mobile,System, x-ray, fluoroscopic, Image-intensified fluoroscopic x-ray system, mobile,System, x-ray, fluoroscopic, image-intensified | 2 | OEC | ||
38 | 00840682115377 | Brivo Plus | JAA,OXO | System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x- System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x-ray system, mobile | 2 | OEC | ||
39 | 00840682115360 | Brivo Prime | JAA,OXO | System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x- System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x-ray system, mobile | 2 | OEC | ||
40 | 00840682106139 | WDR1 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | WIRELESS DR IMAGING OPTION | ||
41 | 00195278502582 | Elite MiniView | MEDICAL DEVICE, UDI LABEL PLACEMENT, MiniView | JAA,OXO | System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x- System, x-ray, fluoroscopic, image-intensified,Image-intensified fluoroscopic x-ray system, mobile | 2 | OEC | |
42 | 00195278469700 | Apex Select | B7919QT-B7919QS | Revolution Apex Select - Designated System Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
43 | 00195278403087 | Eagle | Revolution Eagle designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
44 | 00195278385215 | Advance | Revolution Advance designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
45 | 00195278362247 | Frontier ES | Revolution Frontier ES for EOL CT Designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
46 | 00195278362230 | Frontier MDR | Revolution Frontier for EOL CT Designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
47 | 00195278118356 | Tempo | B2401CAB | Definium Tempo System UDI | KPR,IZF,MQB | System, x-ray, stationary,System, x-ray, tomographic,Solid state x-ray imager (f System, x-ray, stationary,System, x-ray, tomographic,Solid state x-ray imager (flat panel/digital imager) | 2 | Definium |
48 | 00840682146210 | XR656 | KPR | System, x-ray, stationary | 2 | Discovery | ||
49 | 00840682138598 | XR656 HD | KPR,MQB,IZF | System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager),S System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager),System, x-ray, tomographic | 2 | Discovery | ||
50 | 00840682118699 | RT | Discovery RT designated medical device | JAK | System, x-ray, tomography, computed | 2 | Discovery |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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 |
2 | 10862318000311 | IMA-4600 | Digital X-Ray Sensor | BIOK-4600 | BIOKINEMETRICS, INC. | |
3 | 10815411020298 | GMR40 | GMR40 Retrofit Kit | NEUROLOGICA CORP. | ||
4 | 10815112020214 | 600001 | 600001 | Fast Find Grid | Fast Find Grid: Disposable CT Biopsy Grid | BRACCO DIAGNOSTICS INC |
5 | 10746190002826 | 705560 | HYDRA VISION DIGITAL IMAGING SYSTEM, 80KW SYSTEM | LF | LIEBEL-FLARSHEIM COMPANY LLC | |
6 | 10746190002819 | 705559 | HYDRA VISION DIGITAL IMAGING SYSTEM, 65KW SYSTEM | LF | LIEBEL-FLARSHEIM COMPANY LLC | |
7 | 10746190002475 | 700560 | Direct Digital Urology Imaging System, 80 kW | LF | LIEBEL-FLARSHEIM COMPANY LLC | |
8 | 10746190002468 | 700559 | Direct Digital Urology Imaging System, 64kW | LF | LIEBEL-FLARSHEIM COMPANY LLC | |
9 | 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 |
10 | 08904269409531 | 303-000783-4 | Skanrad 400 is an advanced high frequency type X-ray system designed for superio Skanrad 400 is an advanced high frequency type X-ray system designed for superior image quality for radiographic use with powerful 32 kW generator and very low X-ray leakage radiation | SKANRAD 400 | SKANRAY TECHNOLOGIES LIMITED | |
11 | 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 | |
12 | 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. |
13 | 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. | |
14 | 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. | |
15 | 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. | |
16 | 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. |
17 | 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. |
18 | 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. | |
19 | 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. | |
20 | 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. |
21 | 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 |
22 | 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 |
23 | 08809413810488 | ExamVue DR | The ExamVue DR software is designed for use by radiologists and radiology techni The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol. | Box for ExamVue DR(outside 265mmx185mmx150mm) | JPI HEALTHCARE. CO., LTD. | |
24 | 08809413810143 | ExamVue DR | The ExamVue DR software is designed for use by radiologists and radiology techni The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol. | ExamVue | JPI HEALTHCARE. CO., LTD. | |
25 | 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. | |
26 | 08809394330340 | FXRD-4343VAW PLUS | Flat Panel Detector, wireless43cm by 43 cm of size | VIVIX-S 4343VAW PLUS | VIEWORKS CO., LTD. | |
27 | 08809394330333 | FXRD-4343VAW | Flat Panel Detector, wireless43cm by 43cm of size | VIVIX-S 4343VAW | VIEWORKS CO., LTD. | |
28 | 08809394330326 | FXRD-3643VAW PLUS | Flat Panel Detector, wireless36cm by 43 cm of size | VIVIX-S 3643VAW PLUS | VIEWORKS CO., LTD. | |
29 | 08809394330319 | FXRD-3643VAW | Flat Panel Detector, wireless36cm by 43 cm of size | VIVIX-S 3643VAW | VIEWORKS CO., LTD. | |
30 | 08809394330302 | FXRD-2530VAW PLUS | Flat Panel Detector, wireless25cm by 30 cm of size | VIVIX-S 2530VAW PLUS | VIEWORKS CO., LTD. | |
31 | 08809394330296 | FXRD-2530VAW | Flat Panel Detector of 25 cm by 30 cm size. Wireless | VIVIX-S 2530VAW | VIEWORKS CO., LTD. | |
32 | 08809394330289 | FXRD-1751SB | Solid State X-ray Imager (Flat Panel/Digital Imager) | VIVIX-S 1751S | VIEWORKS CO., LTD. | |
33 | 08809394330258 | FXRD-1717VA | Solid State X-ray Imager (flat panel/digital imager) | VIVIX-S 1717V | VIEWORKS CO., LTD. | |
34 | 08809394330241 | FXRD-1717VA | Solid State X-ray Imager (Flat panel/ digital imager) | VIVIX-S 1717V | VIEWORKS CO., LTD. | |
35 | 08809394330234 | FXRD-1417NBW | VIVIX-S 1417N | VIEWORKS CO., LTD. | ||
36 | 08809394330227 | FXRD-1417NAW | VIVIX-S 1417N | VIEWORKS CO., LTD. | ||
37 | 08809394330210 | FXRD-1717NBW | FXRD-1717N | VIEWORKS CO., LTD. | ||
38 | 08809394330203 | FXRD-1717NAW | FXRD-1717N | VIEWORKS CO., LTD. | ||
39 | 08809394330197 | FXRD-1717NB | FXRD-1717N | VIEWORKS CO., LTD. | ||
40 | 08809394330180 | FXRD-1717NA | FXRD-1717N | VIEWORKS CO., LTD. | ||
41 | 08809394330173 | FXRD-1012NBW | FXRD-1012N | VIEWORKS CO., LTD. | ||
42 | 08809394330166 | FXRD-1012NAW | FXRD-1012N | VIEWORKS CO., LTD. | ||
43 | 08809394330111 | FXRD-1417WB | ViVIX-S Wireless | VIEWORKS CO., LTD. | ||
44 | 08809394330104 | FXRD-1417WA | VIVIX-S Wireless | VIEWORKS CO., LTD. | ||
45 | 08809394330081 | FXRD-1417SB | ViVIX-S with VXvue | VIEWORKS CO., LTD. | ||
46 | 08809394330050 | FXRD-1417SA | ViVIX-S with VXvue | VIEWORKS CO., LTD. | ||
47 | 08809394330036 | FXRD-1717SB | ViVIX-S wiht VXvue | VIEWORKS CO., LTD. | ||
48 | 08809394330005 | FXRD-1717SA | ViVIX-S with VXvue | VIEWORKS CO., LTD. | ||
49 | 08809378240245 | Prudent1212 | The Prudent is an Wireless/Wired flat panel x-ray detector system that interface The Prudent is an Wireless/Wired flat panel x-ray detector system that interfaces with, and acquires and digitized x-ray exposures from, standard radiographic system. The Prudent detector is designed to be used in any environment that would typically use a radiographic cassette for examination of human anatomy. The detector will display high quality images in approximately five seconds over a wide range of dose setting.The digital x-ray detector is configurable in several options depending materials such as TFT array(amorphous silicon or Indium Gallium Zinc Oxide), TFT substrate (glass or polyimide), TFT Pixel pitch and Scintillator (CsI or Gadox). | Prudent1212 | PIXXGEN CORPORATION | |
50 | 08809378240207 | Prudent1417 | The Prudent is an Wireless/Wired flat panel x-ray detector system that interface The Prudent is an Wireless/Wired flat panel x-ray detector system that interfaces with, and acquires and digitized x-ray exposures from, standard radiographic system. The Prudent detector is designed to be used in any environment that would typically use a radiographic cassette for examination of human anatomy. The detector will display high quality images in approximately five seconds over a wide range of dose setting.The digital x-ray detector is configurable in several options depending materials such as TFT array(amorphous silicon or Indium Gallium Zinc Oxide), TFT substrate (glass or polyimide), TFT Pixel pitch and Scintillator (CsI or Gadox). | Prudent1417 | PIXXGEN CORPORATION |