FDA 510(k) Applications for Medical Device Product Code "QDQ"

FDA 510(k) Number Applicant Device Name Decision Date
K220105 DeepHealth, Inc. Saige-Dx 05/12/2022
K201019 Hologic, Inc. Genius AI Detection 11/18/2020
K221449 Hologic, Inc. Genius AI Detection 2.0 10/06/2022
K230096 Hologic, Inc. Genius AI Detection 2.0 with CC-MLO Correlation 05/23/2023
K182373 iCAD Inc. PowerLook Tomo Detection V2 Software 12/06/2018
K191994 iCAD Inc. ProFound AI Software V2.1 10/04/2019
K203822 iCAD Inc. ProFound AI Software V3.0 03/12/2021
K211678 Lunit Inc. Lunit INSIGHT MMG 11/17/2021
K212783 ScanMed, LLC ProstatID 07/08/2022
K192287 Screenpoint Medical B.V. Transpara 12/10/2019
K193229 ScreenPoint Medical B.V. Transpara 03/05/2020
K210404 ScreenPoint Medical B.V. Transpara 1.7.0 06/02/2021
K221347 ScreenPoint Medical B.V. Transpara 1.7.2 08/03/2022
K181704 ScreenPoint Medical BV Transpara 11/21/2018
K210670 TaiHao Medical Inc. BU-CAD 12/21/2021
K192854 Therapixel MammoScreen 03/25/2020
K211541 Therapixel MammoScreen 2.0 11/26/2021


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