| 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 | 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 | 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 | |
| 2 | 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 | |
| 3 | 08908002051063 | V2 | MAXIO V2 is a stereotactic accessory intended for the spatial positioning and or MAXIO V2 is a stereotactic accessory intended for the spatial positioning and orientation of an instrument guide to assist in manual advancement of one or more instruments for image guided procedures. It provides Preoperative planning and intra operative guidance to the surgeon by visually representing the targeted path and position(s) on the image based model of the target organ along with the data provided by the instrument manufacturer. | MAXIO | PERFINT HEALTHCARE PRIVATE LIMITED | |
| 4 | 08800025300084 | 1.1 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
| 5 | 08800025300077 | 1.1 | AVIEW | CORELINE SOFT CO.,LTD. | ||
| 6 | 08800025300039 | 1.0 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
| 7 | 08033837932994 | NewTom 7G | 70V10000 | The device NewTom 7G is a cone beam computed tomography X-ray system. It is inte The device NewTom 7G is a cone beam computed tomography X-ray system. It is intended for diagnostic use obtaining geometric information and radiologic density from two-dimensional and three-dimensional images of anatomic particulars and objects in the examined area. | NewTom | CEFLA SOCIETA' COOPERATIVA |
| 8 | 08033837931379 | NewTom 5G XL | P70720008 | X-ray imaging device comprising an X-ray acquisition system, for producing two a X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display. | NewTom | CEFLA SOCIETA' COOPERATIVA |
| 9 | 08033837931362 | NewTom 5G | P70720000 | X-ray imaging device comprising an X-ray acquisition system, for producing two a X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display. | NewTom | CEFLA SOCIETA' COOPERATIVA |
| 10 | 07640167222131 | 2.0 | CAS-One IR | CASCINATION AG | ||
| 11 | 07290108670127 | VERITON CT 16 | 8010172-01 | Single Photon Emission Computed Tomography System combined with a Computed Tomog Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging. | VERITON CT | SPECTRUM DYNAMICS MEDICAL, INC |
| 12 | 07290108670110 | VERITON CT 64 | 8010142-01 | Single Photon Emission Computed Tomography System combined with a Computed Tomog Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging, | VERITON CT | SPECTRUM DYNAMICS MEDICAL, INC |
| 13 | 07290018016114 | 1.1 | HealthOST | NANO-X AI LTD | ||
| 14 | 07290018016091 | 1.0 | HealthCCSng | NANO-X AI LTD | ||
| 15 | 07290018016008 | 3.0.0 | HealthCCS | NANO-X AI LTD | ||
| 16 | 07290017702254 | D | XR-ACE-SYS | XACT ACE Robotic System | ACE | XACT ROBOTICS LTD |
| 17 | 07290016836202 | 1.0 | Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check function Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, inaccordance with the Dose Check feature that is specified by the NEMA XR-25 Standard. Thedevice is a software and hardware system which includes Computer, dedicated display andcontrols. The SafeCT-29 is interfaced to CT scanners that are not equipped with the DoseCheck function. The device is connected to the CT Console video output via a standard videoconnector. The SafeCT-29 Computer’s internal video splitter captures the CT Console displayvideo, in real time, without affecting neither the CT console itself nor its display. This analogvideo signal is digitized by a video grabber. The SafeCT-29 software analyzes the digital inputvideo using OCR software continuously. The radiation dose information as calculated by thescanner and displayed to the CT operator is extracted and analyzed in real time. The SafeCT-29 captures the video of the CT Console display in real time, without affecting neither the CTconsole itself nor its display and workflow. As specified by NEMA XR-25 Standard, thesafeCT-29 notifies and alerts the CT operators, prior to a scan, if the estimated dose index isabove the predefined values set by the operating group, practice, or organization. SafeCT-29prevents continuing an over-the-limit scan unless dose levels are reconfirmed by the operator,in accordance with NEMA XR-29*.The device records the details of such events, includingthe operator details and decisions. This record is available to the user. | SafeCT-29 | MEDIC VISION - IMAGING SOLUTIONS LTD | |
| 18 | 07290016484007 | Spotlight | The CardioGraphe is a CT Scanner designed to provide images of scanned organs es The CardioGraphe is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system. | CardioGraphe | ARINETA LTD | |
| 19 | 06971576832057 | uMI 550 | uMI | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | ||
| 20 | 06971576832040 | uEXPLORER | Positron Emission Tomography and Computed Tomography System | uEXPLORER | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | |
| 21 | 06971576832026 | uMI 550 | Positron Emission Tomography and Computed Tomography System | uMI | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | |
| 22 | 06971576831104 | uCT ATLAS | uCT | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | ||
| 23 | 06971576831043 | uCT 760 | Computed Tomography X-ray System | uCT | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | |
| 24 | 06971576831036 | uCT 550 | Computed Tomography X-ray System | uCT | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | |
| 25 | 06971576831012 | uCT 530 | Computed Tomography X-ray System | uCT | SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD. | |
| 26 | 06970167440084 | NeuViz 16 Essence | NeuViz 16 Essence Multi-Slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 27 | 06970167440077 | NeuViz Prime | NeuViz Prime Multi-Slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 28 | 06970167440060 | NeuSight PET/CT 16 | NeuSight PET/CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 29 | 06970167440053 | NeuSight PET/CT 64 | NeuSight PET/CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 30 | 06970167440046 | NeuViz 128 | NeuViz 128 Multi-slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 31 | 06970167440039 | NeuViz 64 En | NeuViz 64 Multi-slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 32 | 06970167440022 | NeuViz 64 In | NeuViz 64 Multi-slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 33 | 06970167440015 | NeuViz 64e | NeuViz 64 Multi-slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 34 | 06970167440008 | NeuViz 64i | NeuViz 64 Multi-slice CT Scanner System | NEUSOFT MEDICAL SYSTEMS CO., LTD. | ||
| 35 | 06009880828166 | eXero-dr | CL-08-0013-H2 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 36 | 06009880828159 | Xmplar-dr | CL-08-0015-B2 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 37 | 06009880828142 | eXero-dr | CL-08-0013-H4 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 38 | 06009880828135 | Xmplar-dr | CL-08-0013-A11 | The Xmplar-dr is a full-body, low-dose X-ray scanner which produce digital X-ray The Xmplar-dr is a full-body, low-dose X-ray scanner which produce digital X-ray images used for diagnosis purpose in both trauma and general radiography cases, as well as forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 39 | 06009880828128 | eXero-dr | CL-08-0013-H11 | The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposesin both trauma and general radiography cases as well as in forensic pathology cases. | Lodox | LODOX SYSTEMS (PTY) LTD |
| 40 | 06009880828111 | Xmplar-dr | CL-08-0015-B1 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 41 | 06009880828104 | Xmplar-dr | CL-08-0012-A8 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 42 | 06009880828098 | Xmplar-dr | CL-08-0012 | The Xmplar-dr is a full body, low dose, x-ray scanner which produce digital x-ra The Xmplar-dr is a full body, low dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiology cases, as well as forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 43 | 06009880828081 | eXero-dr | CL-08-0016-I2 | The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ra The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases. | LODOX | LODOX SYSTEMS (PTY) LTD |
| 44 | 06009880828074 | eXero-dr | CL-08-0013-H7 | The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiography cases as well as in forensic pathology cases. | Lodox | LODOX SYSTEMS (PTY) LTD |
| 45 | 06009880828067 | eXero-dr | CL-08-0013-H6 | The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiography cases as well as in forensic pathology cases. | Lodox | LODOX SYSTEMS (PTY) LTD |
| 46 | 05700002173614 | v.1. | RBknee | RADIOBOTICS APS | ||
| 47 | 04987670103810 | PCD-1000A | This device is used to acquire transaxial images of any desired region of the bo This device is used to acquire transaxial images of any desired region of the body, providing a wide range of diagnostic capabilities. | PET-CT SCANNER | CANON MEDICAL SYSTEMS CORPORATION | |
| 48 | 04987670103797 | TSX-306A | CT SCANNER | CANON MEDICAL SYSTEMS CORPORATION | ||
| 49 | 04987670102912 | TSX-303B | This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name TOSHIBA SCANNER.Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now CT SCANNER . | TOSHIBA SCANNER | CANON MEDICAL SYSTEMS CORPORATION | |
| 50 | 04987670102691 | TSX-304A | CT SCANNER | CANON MEDICAL SYSTEMS CORPORATION |