| 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 | 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 | ||
| 28 | 00840682147392 | Maxima US | Revolution Maxima CT designated medical device, WSO make | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
| 29 | 00840682146197 | ACT LMB | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
| 30 | 00840682146180 | Maxima | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
| 31 | 00840682146159 | Ace | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
| 32 | 00840682137553 | Frontier | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
| 33 | 00840682135313 | ACT | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
| 34 | 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 | ||
| 35 | 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 | ||
| 36 | 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 | ||
| 37 | 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 | ||
| 38 | 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 | ||
| 39 | 00840682106139 | WDR1 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | WIRELESS DR IMAGING OPTION | ||
| 40 | 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 | |
| 41 | 00195278469700 | Apex Select | B7919QT-B7919QS | Revolution Apex Select - Designated System Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
| 42 | 00195278403087 | Eagle | Revolution Eagle designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
| 43 | 00195278385215 | Advance | Revolution Advance designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
| 44 | 00195278362247 | Frontier ES | Revolution Frontier ES for EOL CT Designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
| 45 | 00195278362230 | Frontier MDR | Revolution Frontier for EOL CT Designated medical device | JAK | System, x-ray, tomography, computed | 2 | Revolution | |
| 46 | 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 |
| 47 | 00195278070265 | Tempo Pro | B2402CAB | Definium Tempo Pro System UDI | MQB,IZF,KPR | Solid state x-ray imager (flat panel/digital imager),System, x-ray, tomographic, Solid state x-ray imager (flat panel/digital imager),System, x-ray, tomographic,System, x-ray, stationary | 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 | 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 | |
| 2 | 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. | |
| 3 | 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. | |
| 4 | 08809246620032 | TITAN 11 | TITAN 11 | TITAN 11 is a diagnostic DR System that contains high output capacity and high-r TITAN 11 is a diagnostic DR System that contains high output capacity and high-resolution image processing system. During a surgery, the presence of lesions, size, and location can be recorded easily as Radiography images. The important images can be stored within the device so taking Radiography images is convenient. | SYSTEM, X-RAY, STATIONARY | GEMSS MEDICAL SYSTEMS CO.,LTD. |
| 5 | 08806088670560 | GC70 | The GC70 Digital X-ray Imaging System is intended for use in generating radiogra The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 6 | 08806088566313 | GU60A | The GU60A Digital X-ray Imaging Systems are intended for use in generating radio The GU60A Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 7 | 08806088565231 | GC85A | The GC85A Digital X-ray Imaging System is intended for use in generating radiogr The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 8 | 08806088520971 | GU60A-65 | The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating ra The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 9 | 08806088351889 | GF50A | The GF50A Digital X-ray Imaging System is intended for use in generating radiogr The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 10 | 08806088351872 | GF50 | The GF50 Digital X-ray Imaging System is intended for use in generating radiogra The GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 11 | 08806086403467 | GC80 | The GC80 Series Digital X-ray imaging System is intended for use in generating r The GC80 Series Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 12 | 08800018404003 | FLAATZ 500 | The FLAATZ 500 detector is a direct conversion device in the form of a square pl The FLAATZ 500 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor. | FLAATZ | DRTECH CORPORATION | |
| 13 | 08800011140885 | DIAMOND-5A | 220-230V~/150kV | DRGEM | DRGEM CORPORATION | |
| 14 | 08800011140878 | GXR-82SD | 380V3~ / 150kV | DRGEM | DRGEM CORPORATION | |
| 15 | 08800011140861 | GXR-68SD | 380V3~ / 150kV | DRGEM | DRGEM CORPORATION | |
| 16 | 08800011140854 | GXR-52SD | 380V3~ / 150kV | DRGEM | DRGEM CORPORATION | |
| 17 | 08800011140847 | GXR-40SD | 380V3~ / 150kV | DRGEM | DRGEM CORPORATION | |
| 18 | 08800011140830 | GXR-40SD | 380V3~ / 125kV | DRGEM | DRGEM CORPORATION | |
| 19 | 08800011140823 | GXR-32SD | 380V3~ / 150kV | DRGEM | DRGEM CORPORATION | |
| 20 | 08800011140816 | GXR-32SD | 380V3~ / 125kV | DRGEM | DRGEM CORPORATION | |
| 21 | 08800011140809 | SGXR-U40SD | *Line power rating: 100-240V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 22 | 08800011140793 | SGXR-U40SD | *Line power rating: 100-240V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 23 | 08800011140786 | SGXR-U32SD | *Line power rating: 100-240V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 24 | 08800011140779 | SGXR-U32SD | *Line power rating: 100-240V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 25 | 08800011140762 | SGXR-C52SD | *Line power rating: 220-230V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 26 | 08800011140755 | SGXR-C52SD | *Line power rating: 220-230V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 27 | 08800011140748 | SGXR-C52SD | *Line power rating: 110-120V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 28 | 08800011140731 | SGXR-C52SD | *Line power rating: 110-120V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 29 | 08800011140724 | SGXR-C40SD | *Line power rating: 220-230V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 30 | 08800011140717 | SGXR-C40SD | *Line power rating: 220-230V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 31 | 08800011140700 | SGXR-C40SD | *Line power rating: 110-120V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 32 | 08800011140694 | SGXR-C40SD | *Line power rating: 110-120V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 33 | 08800011140687 | SGXR-C32SD | *Line power rating: 220-230V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 34 | 08800011140670 | SGXR-C32SD | *Line power rating: 220-230V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 35 | 08800011140663 | SGXR-C32SD | *Line power rating: 110-120V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 36 | 08800011140656 | SGXR-C32SD | *Line power rating: 110-120V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 37 | 08800011140649 | SGXR-82SD | *Line power rating: 480V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 38 | 08800011140632 | SGXR-82SD | *Line power rating: 400V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 39 | 08800011140625 | SGXR-82SD | *Line power rating: 380V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 40 | 08800011140618 | SGXR-68SD | *Line power rating: 480V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 41 | 08800011140601 | SGXR-68SD | *Line power rating: 400V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 42 | 08800011140595 | SGXR-68SD | *Line power rating: 380V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 43 | 08800011140588 | SGXR-52SD | *Line power rating: 480V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 44 | 08800011140571 | SGXR-52SD | *Line power rating: 400V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 45 | 08800011140564 | SGXR-52SD | *Line power rating: 380V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 46 | 08800011140557 | SGXR-40SD | *Line power rating: 480V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 47 | 08800011140540 | SGXR-40SD | *Line power rating: 400V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 48 | 08800011140533 | SGXR-40SD | *Line power rating: 480V3~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 49 | 08800011140526 | SGXR-40SD | *Line power rating: 400V3~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 50 | 08800011140519 | SGXR-40SD | *Line power rating: 380V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION |