FDA 510(k) Applications for Medical Device Product Code "QDQ"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K241747 | DeepHealth, Inc | Saige-Dx | 11/18/2024 |
| K220105 | DeepHealth, Inc. | Saige-Dx | 05/12/2022 |
| K243688 | DeepHealth, Inc. | Saige-Dx (3.1.0) | 12/19/2024 |
| 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 |
| K240417 | iCAD, Inc. | ProFound Detection (V4.0) | 11/08/2024 |
| K231470 | Lunit Inc. | Lunit INSIGHT DBT | 11/06/2023 |
| K242652 | Lunit Inc. | Lunit INSIGHT DBT v1.1 | 10/04/2024 |
| K211678 | Lunit Inc. | Lunit INSIGHT MMG | 11/17/2021 |
| K242683 | Quibim S.L. | QP-Prostate« CAD | 03/18/2025 |
| 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 |
| K241831 | ScreenPoint Medical B.V. | Transpara (2.1.0) | 11/25/2024 |
| 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 |
| K240697 | See-Mode Technologies Pte. Ltd. | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | 09/09/2024 |
| K241770 | Siemens Healthcare GmbH | Prostate MR AI (VA10A) | 03/05/2025 |
| K210670 | TaiHao Medical Inc. | BU-CAD | 12/21/2021 |
| K192854 | Therapixel | MammoScreen | 03/25/2020 |
| K211541 | Therapixel | MammoScreen 2.0 | 11/26/2021 |
| K240301 | Therapixel | MammoScreen« (3) | 08/01/2024 |
| K243679 | Therapixel | MammoScreen« (4) | 07/03/2025 |
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