Other products from "LUNIT INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 08800076000124 1.0 QFM Radiological Computer-Assisted Prioritization Software For Lesions 2 Lunit INSIGHT CXR Triage
Other products with the same Product Code "QDQ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00860005144013 2.0.1 SDX1000 Saige-Dx is a software device that processes screening mammograms using artifici Saige-Dx is a software device that processes screening mammograms using artificial intelligence to aid interpreting radiologists. By automatically detecting the presence or absence of soft tissue lesions and calcifications in mammography images, Saige-Dx can help improve reader performance, while also reducing reading time. The software takes as input a set of x-ray mammogram DICOM files from a single digital breast tomosynthesis (DBT) study and generates finding-level outputs for each image analyzed, as well as an aggregate case- level assessment. Saige-Dx processes both the DBT image stacks and the associated 2D images (full-field digital mammography (FFDM) and/or synthetic 2D images) in a DBT study. For each image, Saige-Dx outputs bounding boxes circumscribing any detected findings and assigns a Finding Suspicion Level to each finding, indicating the degree of suspicion that the finding is malignant. Saige-Dx uses the results of the finding-level analysis to generate a Case Suspicion Level, indicating the degree of suspicion for malignancy across the case. Saige-Dx encapsulates the finding and case-level results into a DICOM Structured Report (SR) object containing markings that can be overlaid on the original mammogram images using a viewing workstation and a DICOM Secondary Capture (SC) object containing a summary report of the Saige-Dx results. Saige-Dx DEEPHEALTH, INC.
2 00858012005960 2.1 ProFound AI ICAD, INC.
3 00858012005939 V2 PowerLook Tomo Detection (ProFound AI) ICAD, INC.
4 00850008977176 3.0 ProFound AI V3.0 ICAD, INC.
5 B885MAML2US0 MAL2US Radiological computer assisted detection and diagnosis software MammoScreen THERAPIXEL
6 B885MAML0 MAML MAML Radiological computer assisted detection and diagnosis software MammoScreen THERAPIXEL
7 08800076000056 1.1 Lunit INSIGHT MMG LUNIT INC.
8 08719326450131 1.7.y Transpara® software is intended for use as a concurrent reading aid for physicia Transpara® software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®. Transpara SCREENPOINT MEDICAL B.V.
9 08719326450124 1.5.0 2D The ScreenPoint Transpara system is intended for use as a concurrent reading aid The ScreenPoint Transpara system is intended for use as a concurrent reading aid for physicians interpreting screening mammograms from compatible FFDMsystems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes marks placed on suspicious soft tissue lesions and suspicious calcifications, region based scores, displayed upon the physicians query, indicating the likelihood that cancer is present in specific regions, and an overall score indicating the likelihood that cancer is present on the mammogram. Patient management decisions should not be made solely on the basis of analysis by Transpara. Transpara SCREENPOINT MEDICAL B.V.
10 08719326450117 1.x.y Transpara™ software is intended for use as a concurrent reading aid for physicia Transpara™ software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara™. Transpara SCREENPOINT MEDICAL B.V.
11 08719326450100 1.3.y The ScreenPoint Transpara system is intended for use as a concurrent reading aid The ScreenPoint Transpara system is intended for use as a concurrent reading aid for physicians interpreting screening mammograms, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes marks placed on suspicious soft tissue lesions and suspicious calcifications; region‐based scores, displayed upon the physician’s query, indicating the likelihood that cancer is present in specific regions; and an overall score indicating the likelihood that cancer is present on the mammogram. Patient management decisions should not be made solely on the basis of analysis by Transpara. Transpara SCREENPOINT MEDICAL B.V.