| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 15420045515031 | 2050-0104 | 2050-0104 | MWP | Cabinet, x-ray system | 2 | FAXITRON PATH | |
| 2 | 15420045514089 | R15 | R15 | GDF | GUIDE, NEEDLE, SURGICAL | 1 | PERL | |
| 3 | 15420045506909 | Discovery C | KGI | Densitometer, bone | 2 | Discovey C | ||
| 4 | 15420045504110 | ATEC Sapphire 200 | KNW | INSTRUMENT, BIOPSY | 2 | ATEC Sapphire 200 | ||
| 5 | 15420045510333 | 50-250XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MYOSURE XL HYSTEROSCOPY SET | ||
| 6 | 15420045514294 | V5 | NSV5US-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
| 7 | 25420045510330 | 50-250XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MYOSURE XL HYSTEROSCOPY SET | ||
| 8 | 25420045514307 | V5 | NSV5KITUS-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
| 9 | 25420045505107 | 40-902 | 40-902 | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MyoSure Tissue Removal Device | |
| 10 | 15420045514836 | PATHVISION 23x29 | PATHVISION23X29 | MWP | Cabinet, x-ray system | 2 | FAXITRON PATH | |
| 11 | 15420045514300 | V5 | NSV5KITUS-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
| 12 | 15420045512924 | INTERNAL CONTROL-B, 960T, IVD | PRD-06234 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | Panther Fusion | |
| 13 | 15420045512917 | EXTRACTION REAGENTS-B, 960T, IVD | PRD-06232 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | Panther Fusion | |
| 14 | 15420045510906 | GBS CTRLS KIT, PANTHER FUSION, IVD | PRD-04485 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
| 15 | 15420045510890 | GBS KIT, 96T, IVD | PRD-04484 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
| 16 | 15420045510470 | INTERNAL CONTROL-X, 960T, IVD | PRD-04476 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
| 17 | 15420045510463 | EXTRACTION REAGENT-X, 960T, IVD | PRD-04477 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
| 18 | 15420045509641 | System Software | InSight FD | OXO | Image-intensified fluoroscopic x-ray system, mobile | 2 | Flouroscan InSight | |
| 19 | 15420045509375 | CLASS I CONTROL - C. ALBICANS | PRD-04521 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | aptima | |
| 20 | 15420045507937 | 20-401ML | 20-401ML | NWW | Hysteroscope accessories | Myosure Manual Tissue Removal Device | ||
| 21 | 15420045505230 | B90003 | B90003 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | 4.0-5.0 CM CT LUMEN MARKER SET | |
| 22 | 15420045505193 | B11245 | B11245 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | 4-5 CM CONTURAFLEX MLB CATHETER w/TRI INTRODUCER | |
| 23 | 15420045505094 | 50-501XL | 50-501XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
| 24 | 15420045505087 | 50-401XL | 50-401XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MyoSure Tissue Removal Device | |
| 25 | 15420045505070 | 30-401LITE | 30-401LITE | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
| 26 | 15420045505001 | 919007-01 | 919007-01 | JAQ | System, applicator, radionuclide, remote-controlled | Mammosite Variable 4-5 cm Applicator Tray | ||
| 27 | 15420045504998 | EVIVA_1213-20 | EVIVA_1213-20 | KNW | INSTRUMENT, BIOPSY | EVIVA_1213-20 | ||
| 28 | 15420045504950 | EVIVA_0910-20 | EVIVA_0910-20 | KNW | INSTRUMENT, BIOPSY | EVIVA_0910-20 | ||
| 29 | 15420045504813 | 10-401 | 10-401 | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
| 30 | 15420045501140 | 2000 | NS2000US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure | ||
| 31 | 15420045501133 | 2007 | NS2007US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure SureSound | ||
| 32 | 15420045501126 | 2013 | NS2013KITUS | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure SureSound | ||
| 33 | 15420045501119 | 2013 | NS2013US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure | ||
| 34 | 15420045501065 | Cervista HTA System Computer | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
| 35 | 15420045500969 | Cervista HTA System | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
| 36 | 15420045500952 | Cervista HTA System | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
| 37 | 15420045500860 | NovaSure Controller | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | 3 | NovaSure | ||
| 38 | 15420045500853 | NovaSure Controller | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | 3 | NovaSure | ||
| 39 | 15420045512474 | GENIUS AI DETECTION SOFTWARE | OTE | Digital breast tomosynthesis | 3 | GENIUS AI DETECTION | ||
| 40 | 25420045510064 | FILTER, THINPREP UROCYTE 100 PACK | 70472-001 | KET | FILTERS, CELL COLLECTION, TISSUE PROCESSING | ThinPrep | ||
| 41 | 25420045510057 | THINPREP SLIDES UROCYTE, 100 pk | 70471-001 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
| 42 | 25420045509990 | THINPREP MICROSCOPE, ARCLESS, 72pk | 70126-002 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
| 43 | 25420045509679 | NON-GYN Slides | 70372-001 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
| 44 | 25420045509662 | NON-GYN Filters, 100 pack | 70205-001 | KET | FILTERS, CELL COLLECTION, TISSUE PROCESSING | ThinPrep | ||
| 45 | 25420045508467 | UroCyte Vial | 70473-001 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
| 46 | 25420045505039 | 819001 | 819001 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Neucletron HDR Afterloader Connectors wObturators | |
| 47 | 15420045514775 | PRESERVCYT VIAL | PRD-07129 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
| 48 | 15420045514621 | UroCyte Vial | ASY-15509 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
| 49 | 15420045514614 | CytoLyt Cup | PRD-07065 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
| 50 | 15420045514607 | CytoLyt Tube | PRD-07064 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep |
| 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 |