| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | INTUITION7 | AQNet Server | The AquariusNET Server, also known as iNtuition Server, receives, stores, transm The AquariusNET Server, also known as iNtuition Server, receives, stores, transmits and post-processes medical images from acquisition devices, in both DICOM and non-DICOM format. | LLZ | System, Image Processing, Radiological | 2 | iNtuition | |
| 2 | INTUITION6 | Aquarius Web | AquariusWeb Viewer (aka AqWeb or Web Viewer, marketing term) is a version of iNt AquariusWeb Viewer (aka AqWeb or Web Viewer, marketing term) is a version of iNtuitionEMV with a focus on 3D rendering, additionally providing workflow and scene support. | LLZ | System, Image Processing, Radiological | 2 | iNtuition | |
| 3 | INTUITION5 | iNtuition Mobile | iNtuition Mobile (aka AQMobile) refers to the client viewer designed for mobile devices. | LLZ | System, Image Processing, Radiological | 2 | iNtuition | |
| 4 | INTUITION4 | iNtuitionEMV | iNtuitionEMV (aka iEMV) is a “zero footprint” 2D/basic 3D image client viewer ru iNtuitionEMV (aka iEMV) is a “zero footprint” 2D/basic 3D image client viewer running within a web browser. Limited to the context of iEMV usage on a mobile device, it is referred to as iEMV Mobile. | LLZ | System, Image Processing, Radiological | 2 | iNtuition | |
| 5 | INTUITION2 | ThinClient | ThinClient (aka AquariusNET Viewer or AquariusNET ThinClient) is a client viewer ThinClient (aka AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3D image viewing capabilities. | LLZ | System, Image Processing, Radiological | 2 | iNtuition | |
| 6 | INTUITION1 | Aquarius iNtuition Client | Aquarius iNtuition Client (aka AQi, Aquarius Workstation, or Aquarius Workstatio Aquarius iNtuition Client (aka AQi, Aquarius Workstation, or Aquarius Workstation iNtuition Client) is the most comprehensive client viewer with 2D/3D/4D image processing and visualization capabilities. | LLZ | System, Image Processing, Radiological | 2 | iNtuition | |
| 7 | AQAPS1 | AquariusAPS | The AquariusAPS server is a stand-alone medical device software which performs v The AquariusAPS server is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according to user pre-configured rules and schedules. | LLZ | System, Image Processing, Radiological | 2 | AquariusAPS | |
| 8 | B220843002A8430031 | Eureka AI Interoperability Platform | An application software program designed to function as a portal to allow softwa An application software program designed to function as a portal to allow software providers to make available radiological interpretive software [typically artificial intelligence (AI) based] for radiology professionals to access, use, evaluate, and compare. It is intended to facilitate distribution and hospital implementation of algorithms designed to assist image interpretation within a healthcare facility. | LMD | System, Digital Image Communications, Radiological | 1 | Eureka | |
| 9 | B2208430011 | Eureka AI Results Explorer | Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms. | LMD | System, Digital Image Communications, Radiological | 1 | Eureka | |
| 10 | AQAPS04 | AQAPS04 | AQAPS | AQAPS, also known as AquariusAPS Server, is a stand-alone medical device softwar AQAPS, also known as AquariusAPS Server, is a stand-alone medical device software which performs various kinds of data processing on incoming DICOM data sets, according to user pre-configured rules and schedules. | LLZ | System, Image Processing, Radiological | 2 | AQAPS |
| 11 | INTUITION9 | Intuition Thin Client | Intuition Thin Client (aka ThinClient and AquariusNET Viewer or AquariusNET Thin Intuition Thin Client (aka ThinClient and AquariusNET Viewer or AquariusNET ThinClient) is a client viewer with basic 2D/3D image viewing capabilities. | LLZ | System, Image Processing, Radiological | 2 | Intuition | |
| 12 | INTUITION8 | Intuition Client | Intuition Client (aka Aquarius iNtuition Client, AQi, Aquarius Workstation, or A Intuition Client (aka Aquarius iNtuition Client, AQi, Aquarius Workstation, or Aquarius Workstation iNtuition Client) is the most comprehensive client viewer with 2D/3D/4D image processing and visualization capabilities. | LLZ | System, Image Processing, Radiological | 2 | Intuition | |
| 13 | INTUITION12 | Intuition Server | The Intuition Server (aka AquariusNET Server and iNtuition Server) receives, sto The Intuition Server (aka AquariusNET Server and iNtuition Server) receives, stores, transmits and post-processes medical images from acquisition devices in DICOM and non-DICOM formats. | LLZ | System, Image Processing, Radiological | 2 | Intuition | |
| 14 | INTUITION11 | Intuition Web | Intuition Web (aka AquariusWeb Viewer and AqWeb or Web Viewer, marketing term) i Intuition Web (aka AquariusWeb Viewer and AqWeb or Web Viewer, marketing term) is a version of Intuition EMV (aka iNtuitionEMV) with a focus on 3D rendering, additionally providing workflow and scene support. | LLZ | System, Image Processing, Radiological | 2 | Intuition | |
| 15 | INTUITION10 | Intuition Mobile | Intuition Mobile ( aka iNtuition Mobile and AQMobile) refers to the client viewe Intuition Mobile ( aka iNtuition Mobile and AQMobile) refers to the client viewer designed for mobile devices. | LLZ | System, Image Processing, Radiological | 2 | Intuition | |
| 16 | INTUITION04 | Intuition04 | Intuition | Intuition (also referred to as Aquarius Intuition) is a medical device comprised Intuition (also referred to as Aquarius Intuition) is a medical device comprised of two stand-alone software components: a server software backend (Intuition Server) which performs complex image post processing and client viewer software (Intuition Client Viewers) that provides a user interface, enabling the user to view medical image data and associated derived metadata. The Intuition client viewer/server software enables 2D/3D/4D (3D with the dimension of time) image review, volume rendering, communications, storage, reporting, and image post processing. The Intuition software is used with off-the-shelf hardware, including a computer, monitor, keyboard and mouse.Intuition is comprised of six (6) separate client viewers: Intuition Client with Emergency Lung Docker, Intuition Thin Client, Intuition Review, Intuition EMV, Intuition Web Viewer, and Intuition Mobile. | LLZ | System, Image Processing, Radiological | 2 | Intuition |
| 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 |