| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | M722XD20239B200370 | 1.2.0 | ClearRead Bone Suppress on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
| 2 | M722T18304V182920 | 3.3.3 | ClearRead CT | LLZ,OEB | System, Image Processing, Radiological,Lung Computed Tomography System, Computer System, Image Processing, Radiological,Lung Computed Tomography System, Computer-Aided Detection | 2 | ClearRead CT | |
| 3 | M722XD22145T212210 | 4.0.0 | ClearRead Compare on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray Compare | |
| 4 | M722XD21224L212210 | 3.0.0 | ClearRead Confirm Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
| 5 | M722XD21224E212210 | 3.0.0 | ClearRead Enhance Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Enhance Docker | |
| 6 | M722XD21224C212210 | 6.1.0 | ClearRead Detect Docker | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
| 7 | M722XD21224B212210 | 4.0.0 | ClearRead Bone Suppress Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
| 8 | M722XD21012B203200 | 3.0.0 | ClearRead Bone Suppress on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
| 9 | M722XD20239C200370 | 1.2.0 | ClearRead Detect on Docker Platform | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
| 10 | M722XD20104C20370 | 5.3.1 | ClearRead Detect on Docker PlatformPrimary DI number should be M722XD20104C20037 ClearRead Detect on Docker PlatformPrimary DI number should be M722XD20104C200370.Re-entered 12/30/2020. | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
| 11 | M722XD20104C200370 | 1.1.0 | ClearRead Detect on Docker PlatformPrimary DI number mistyped as M722XD20104C203 ClearRead Detect on Docker PlatformPrimary DI number mistyped as M722XD20104C20370.Originally entered on 5/19/2020. | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
| 12 | M722XD20104B20370 | 3.6.2 | ClearRead Bone Suppress on Docker Platform.Primary DI Number should be M722XD201 ClearRead Bone Suppress on Docker Platform.Primary DI Number should be M722XD20104B200370.Re-entered 12/30/2020. | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
| 13 | M722XD20104B200370 | 1.1.0 | ClearRead Bone Suppress on Docker Platform.Primary DI Number mistyped as M722XD2 ClearRead Bone Suppress on Docker Platform.Primary DI Number mistyped as M722XD20104B20370.Originally entered on 5/19/2020 | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
| 14 | M722X21165E211640 | 3.0.0 | ClearRead Enhance on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Enhance Server | |
| 15 | M722X21165C211640 | 6.1.0 | ClearRead Detect on Server | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Server | |
| 16 | M722X20320C203200 | 6.0.0 | ClearRead Xray +Detect on Connect Platform | MYN | Analyzer,Medical Image | 2 | ClearRead Xray +Detect | |
| 17 | M722R11266T00211 | 2.1 | Deltaview on RCP Platform | LLZ | System, Image Processing, Radiological | 2 | Deltaview | |
| 18 | M722R11266C00521 | 5.2.1 | OnGuard on RCP Platform | MYN | Analyzer,Medical Image | 2 | OnGuard | |
| 19 | M722XD21165C211640 | 6.1.0 | ClearRead Detect Docker | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
| 20 | M722XD21165B211640 | 4.0.0 | ClearRead Bone Suppress Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Docker | |
| 21 | M722XD21012C203200 | 3.0.0 | ClearRead Detect on Docker Platform | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Docker | |
| 22 | M722X21224C212210 | 6.1.0 | ClearRead Detect on Server | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Server | |
| 23 | M722XC22145B212210 | 4.0.0 | ClearRead Bone Suppress on Console Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray Bone Suppress | |
| 24 | M722XC21224L212210 | 3.0.0 | ClearRead Confirm Console | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Console | |
| 25 | M722XC21224C212210 | 6.1.0 | ClearRead Detect Console | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Console | |
| 26 | M722XC21165L211640 | 3.0.0 | ClearRead Confirm Console | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Console | |
| 27 | M722XC21165C211640 | 6.1.0 | ClearRead Detect Console | MYN | Analyzer,Medical Image | 2 | ClearRead Detect Console | |
| 28 | M722X22145B212210 | 4.0.0 | ClearRead Bone Suppress on Server Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray Bone Suppress | |
| 29 | M722X21224B212210 | 4.0.0 | ClearRead Bone Suppress on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Server | |
| 30 | M722X21165B211640 | 4.0.0 | ClearRead Bone Suppress on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Bone Suppress Server | |
| 31 | M722X20320T203200 | 4.0.0 | ClearRead Xray +Compare on Connect Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray +Compare | |
| 32 | M722C22112V213240 | 5.5.0 | ClearRead CT Server | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Server | |
| 33 | M722C21343V213240 | 5.2.0 | ClearRead CT Server | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Server | |
| 34 | M722C21133V211240 | 5.0.0 | ClearRead CT Server | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Server | |
| 35 | M722C14295L142720 | 2.0 | ClearRead +Confirm on Connect Platform | LLZ | System, Image Processing, Radiological | 2 | Clear Read +Confirm | |
| 36 | M722XD22145B212210 | 4.0.0 | ClearRead Bone Suppress on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Xray Bone Suppress | |
| 37 | M722XD21165L211640 | 3.0.0 | ClearRead Confirm Docker | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
| 38 | M722Z19154V191210 | 1.0.2 | ClearRead CT Console | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Console | |
| 39 | M722XD20239L200370 | 1.2.0 | ClearRead Confirm on Docker Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
| 40 | M722XD20104L20370 | 2.2.1 | ClearRead Confirm on Docker PlatformPrimary DI Number should be M722XD20104L2003 ClearRead Confirm on Docker PlatformPrimary DI Number should be M722XD20104L200370.Re-entered on 12/30/2020. | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
| 41 | M722XD20104L200370 | 1.1.0 | ClearRead Confirm on Docker PlatformOriginally mistyped as M722XD20104L20370.Ori ClearRead Confirm on Docker PlatformOriginally mistyped as M722XD20104L20370.Originally entered on 5/19/2020. | LLZ | System, Image Processing, Radiological | 2 | ClearRead Confirm Docker | |
| 42 | M722X21224T212210 | 4.0.0 | ClearRead Compare on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Compare Server | |
| 43 | M722X21165T211640 | 4.0.0 | ClearRead Compare on Server | LLZ | System, Image Processing, Radiological | 2 | ClearRead Compare Server | |
| 44 | M722R14273T142720 | 3.1 | ClearRead +Compare on RCP Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead +Compare | |
| 45 | M722R14164T140290 | 3.1 | ClearRead +Compare on RCP Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead +Compare | |
| 46 | M722R14042T140290 | 3.1 | ClearRead +Compare on RCP Platform | LLZ | System, Image Processing, Radiological | 2 | ClearRead +Compare | |
| 47 | M722CC22110V213240 | 5.5.0 | ClearRead CT Console | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Console | |
| 48 | M722CC21343V213240 | 5.2.0 | ClearRead CT Console | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Console | |
| 49 | M722CC21133V211240 | 5.0.0 | ClearRead CT Console | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Console | |
| 50 | M722CC20176V201320 | 1.2.0 | ClearRead CT Console | OEB,LLZ | Lung Computed Tomography System, Computer-Aided Detection,System, Image Processi Lung Computed Tomography System, Computer-Aided Detection,System, Image Processing, Radiological | 2 | ClearRead CT Console |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 09421904268319 | 4.0 | Volpara Density Map 4.0 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 2 | 09421904268289 | 3.4.2 | Volpara Density Map 3.4.2 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 3 | 09421904268258 | 3.4.2 | VolparaDensity 3.4.2 | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 4 | 09421904268241 | 4.0 | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | ||
| 5 | 09421904268166 | 3.4.1 | VolparaDensity 3.4.1 (Volpara Imaging Software 1.5.5.1) | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 6 | 09421904268128 | 3.3 | Volpara Density Map 3.3 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 7 | 09421904268098 | 3.3 | VolparaDensity 3.3 (Volpara Imaging Software 1.5.3 and 1.5.4) | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 8 | 09421904268050 | 3.2 | Volpara Density Map 3.2 | Volpara Density Map | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 9 | 09421904268029 | 3.2 | VolparaDensity 3.2 (Volpara Imaging Software 1.5.2) | VolparaDensity | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 10 | 09358140000024 | 1.2 | SCI0001 | Quicktome | OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T) | |
| 11 | 09358140000017 | 1.1 | SCI0001 | Quicktome | OMNISCIENT NEUROTECHNOLOGY PTY LTD (O8T) | |
| 12 | 09351327000848 | 1.2 | 1200-0000 | OPSInsight™ is intended for use as preoperative surgical planning software to ai OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty. | OPSInsight™ | OPTIMIZED ORTHO PTY LTD |
| 13 | 09351327000091 | 1250-1300 | OPS Plan V.2.0 | Optimized Positioning System (OPS) Plan | OPTIMIZED ORTHO PTY LTD | |
| 14 | 09351327000077 | 1250-1300 | OPS Plan | Optimized Positioning System (OPS) Plan | OPTIMIZED ORTHO PTY LTD | |
| 15 | 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 | |
| 16 | 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 | |
| 17 | 08908008302008 | RADSpa RIS-PACS 4.0 | RADSpa RIS-PACS | RADSpa® | TELERAD TECH PRIVATE LIMITED | |
| 18 | 08809466041112 | 1.2.1.466 | QuantorView is an image viewing software dedicated DICOM images produced by imag QuantorView is an image viewing software dedicated DICOM images produced by imaging equipment (CR, DR, CT, MRI, Ultrasound and etc). QuantorView is a high quality viewing software responsible for displaying PACS image data. It enables physicians to provide medical services by accessing image data and patient information from remote locations. It also enables the images to be stored to the local database of your personal computer allowing database management to operate efficiently. Physicians can utilize the software tools for researching, teaching, teleconferencing and online collaboration. | QuantorView | DIGIRAY CORP. | |
| 19 | 08809413810471 | ExamVue PACS | The ExamVue PACS is a software solution for the storage, sharing, display and vi The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database. | Box for ExamVue PACS(outside 265mmx185mmx150mm) | JPI HEALTHCARE. CO., LTD. | |
| 20 | 08809413810174 | ExamVue PACS | The ExamVue PACS is a software solution for the storage, sharing, display and vi The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database. | ExamVue | JPI HEALTHCARE. CO., LTD. | |
| 21 | 08809278790307 | Xelis Dental 2.0 | Xelis Dental 2.0 | INFINITT HEALTHCARE CO.,LTD. | ||
| 22 | 08809278790192 | INFINITT RT PACS | INFINITT RT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 23 | 08809278790130 | INFINITT PACS 7.0 | INFINITT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 24 | 08809278790123 | INFINITT ULite | INFINITT ULite | INFINITT HEALTHCARE CO.,LTD. | ||
| 25 | 08809278790116 | Xelis Dental | Xelis Dental | INFINITT HEALTHCARE CO.,LTD. | ||
| 26 | 08809278790109 | Xelis Cardiac | Xelis Cardiac | INFINITT HEALTHCARE CO.,LTD. | ||
| 27 | 08809278790093 | Xelis Fusion | Xelis Fusion | INFINITT HEALTHCARE CO.,LTD. | ||
| 28 | 08809278790086 | Xelis 3D | Xelis 3D | INFINITT HEALTHCARE CO.,LTD. | ||
| 29 | 08809278790079 | Xelis | Xelis | INFINITT HEALTHCARE CO.,LTD. | ||
| 30 | 08809278790062 | INFINITT Cardiology PACS | INFINITT Cardiology PACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 31 | 08809278790055 | INFINITT PACS | INFINITT PACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 32 | 08809278790000 | STARPACS | STARPACS | INFINITT HEALTHCARE CO.,LTD. | ||
| 33 | 08806167789466 | USO-U0N5B0K/WR | 5D Viewer | SAMSUNG MEDISON CO., LTD. | ||
| 34 | 08806167761172 | USO-U0N5B0B/WR | 5D VIEWER | SAMSUNG MEDISON CO., LTD. | ||
| 35 | 08800086200064 | V-B-pAb-02 | Veuron-Brain-pAb2 | HEURON CO.,LTD. | ||
| 36 | 08800086200026 | V-B-pAb-01 | Veuron-Brain-pAb | HEURON CO.,LTD. | ||
| 37 | 08800086200019 | V-B-mN1-01 | Veuron-Brain-mN1 | HEURON CO.,LTD. | ||
| 38 | 08800046800006 | 1.1.0 | ClariCT.AI | CLARIPI INC. | ||
| 39 | 08800025300084 | 1.1 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
| 40 | 08800025300077 | 1.1 | AVIEW | CORELINE SOFT CO.,LTD. | ||
| 41 | 08800025300039 | 1.0 | AVIEW LCS | CORELINE SOFT CO.,LTD. | ||
| 42 | 08800025300022 | 1.1 | AVIEW Modeler | CORELINE SOFT CO.,LTD. | ||
| 43 | 08800025300015 | 1.0 | AVIEW | CORELINE SOFT CO.,LTD. | ||
| 44 | 08800023100006 | 1.0 | OnDemand3DTM | CYBERMED INC. | ||
| 45 | 08800022900089 | 1.0 | 1.0 | VARO Plan Software is a stand-alone Windows-based software application to suppor VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry. | VARO Plan | 3D INDUSTRIAL IMAGING CO.,LTD |
| 46 | 08800022900072 | 1.0 | DentiqAir is a software application for the visualization and segmentation of im DentiqAir is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The software is intended to create design outputs to fabricate intraoral mandibular advancement devices used for the reduction of snoring. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems. Output of DentiqAir has not been 510(k) cleared yet. The export of the device design file should only be sent to manufacturer who hold a 510(k) for intraoral mandibular advancement devices using DentiqAir software. The manufacture of the device should occur as per the design specifications provided within the 510(k) clearance. | DentiqAir | 3D INDUSTRIAL IMAGING CO.,LTD | |
| 47 | 08800022900041 | 1.0 | DentiqGuide is a software device used to pre-operatively plan the placement of a DentiqGuide is a software device used to pre-operatively plan the placement of a dental implant and to visualize a patient’s CT image optionally aligned to an optical 3D surface data. Virtual crowns can be used to guide the planning under the final prosthetic aspect. The surgical guide data can be designed then exported to an external system for manufacturing. Key Lock. | DentiqGuide | 3D INDUSTRIAL IMAGING CO.,LTD | |
| 48 | 08800022900003 | 1.0 | 1.0 | Dentiq3D is a 3D visualization software for the analysis of various dental CT da Dentiq3D is a 3D visualization software for the analysis of various dental CT data. Dentiq3D provides intuitive and real-time 3D volume processing functions. | Dentiq3D | 3D INDUSTRIAL IMAGING CO.,LTD |
| 49 | 08800019700357 | 3.3 | EzDent-i is dental imaging software that is intended to provide diagnostic tools EzDent-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment. | EzDent-i | EWOO SOFT CO., LTD | |
| 50 | 08800019700340 | 5.4 | Ez3D-i is dental imaging software that is intended to provide diagnostic tools f Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions. | Ez3D-i | EWOO SOFT CO., LTD |