Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Regulation 892.2090
10510(k)s in 12 months (40 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QDQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Screenpoint Medical B.V. | 7 | 0 |
| DeepHealth, Inc. | 5 | 0 |
| Lunit, Inc. | 5 | 0 |
| Therapixel | 5 | 0 |
| Hologic, Inc. | 4 | 0 |
| Icad, Inc. | 4 | 0 |
| BeamWorks, Inc. | 1 | 0 |
| Median Technologies | 1 | 0 |
| Quantib B.V. | 1 | 0 |
| Quibim S.L. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 2026 | K261517 | qCT Lung (v1.0) Qure.Ai Technologies Pvt. , Ltd., IN | QDQ |
| Aug 14, 2026 | K260898 | Transpara (2.1.0) Screenpoint Medical B.V., NL | QDQ |
| Aug 12, 2026 | K260086 | CadAI-B Dx BeamWorks, Inc., KR | QDQ |
| Jul 28, 2026 | K260303 | See-Mode Augmented Reporting Tool, Breast (SMART-B) See-Mode Technologies Pty, Ltd., AU | QDQ |
| Jun 26, 2026 | K260714 | MammoScreen® (5) Therapixel, FR | QDQ |
| Jun 15, 2026 | K253825 | Saige-Dx DeepHealth, Inc. | QDQ |
| Apr 29, 2026 | K253682 | DeepHealth ProstateAI Quantib B.V., NL | QDQ |
| Apr 23, 2026 | K260320 | Lunit INSIGHT MMG (v1.1.10) Lunit, Inc., KR | QDQ |
| Mar 26, 2026 | K253796 | Lunit INSIGHT DBT (V1.2) Lunit, Inc., KR | QDQ |
| Feb 6, 2026 | K251474 | Median LCS (internal name) / eyonis LCS (trade name) (1.0) Median Technologies, FR | QDQ |
| Aug 11, 2025 | K251873 | Saige-Dx DeepHealth, Inc. | QDQ |
| Jul 31, 2025 | K243341 | Genius AI Detection 2.0 Hologic, Inc. | QDQ |
| Jul 3, 2025 | K243679 | MammoScreen® (4) Therapixel, FR | QDQ |
| Mar 18, 2025 | K242683 | QP-Prostate® CAD Quibim S.L., ES | QDQ |
| Mar 5, 2025 | K241770 | Prostate MR AI (VA10A) Siemens Healthcare GmbH, DE | QDQ |
| Dec 19, 2024 | K243688 | Saige-Dx (3.1.0) DeepHealth, Inc. | QDQ |
| Nov 25, 2024 | K241831 | Transpara (2.1.0) Screenpoint Medical B.V., NL | QDQ |
| Nov 18, 2024 | K241747 | Saige-Dx DeepHealth, Inc. | QDQ |
| Nov 8, 2024 | K240417 | ProFound Detection (V4.0) Icad, Inc. | QDQ |
| Oct 4, 2024 | K242652 | Lunit INSIGHT DBT v1.1 Lunit, Inc., KR | QDQ |
| Sep 9, 2024 | K240697 | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) See-Mode Technologies Pte, Ltd., SG | QDQ |
| Aug 1, 2024 | K240301 | MammoScreen® (3) Therapixel, FR | QDQ |
| Nov 6, 2023 | K231470 | Lunit INSIGHT DBT Lunit, Inc., KR | QDQ |
| May 23, 2023 | K230096 | Genius AI Detection 2.0 with CC-MLO Correlation Hologic, Inc. | QDQ |
| Oct 6, 2022 | K221449 | Genius AI Detection 2.0 Hologic, Inc. | QDQ |
| Aug 3, 2022 | K221347 | Transpara 1.7.2 Screenpoint Medical B.V., NL | QDQ |
| Jul 8, 2022 | K212783 | ProstatID Scanmed, LLC | QDQ |
| May 12, 2022 | K220105 | Saige-Dx DeepHealth, Inc. | QDQ |
| Dec 21, 2021 | K210670 | BU-CAD Taihao Medical, Inc., TW | QDQ |
| Nov 26, 2021 | K211541 | MammoScreen 2.0 Therapixel, FR | QDQ |
| Nov 17, 2021 | K211678 | Lunit INSIGHT MMG Lunit, Inc., KR | QDQ |
| Jun 2, 2021 | K210404 | Transpara 1.7.0 Screenpoint Medical B.V., NL | QDQ |
| Mar 12, 2021 | K203822 | ProFound AI Software V3.0 Icad, Inc. | QDQ |
| Nov 18, 2020 | K201019 | Genius AI Detection Hologic, Inc. | QDQ |
| Mar 25, 2020 | K192854 | MammoScreen Therapixel, FR | QDQ |
| Mar 5, 2020 | K193229 | Transpara Screenpoint Medical B.V., NL | QDQ |
| Dec 10, 2019 | K192287 | Transpara Screenpoint Medical B.V., NL | QDQ |
| Oct 4, 2019 | K191994 | ProFound AI Software V2.1 Icad, Inc. | QDQ |
| Dec 6, 2018 | K182373 | PowerLook Tomo Detection V2 Software Icad, Inc. | QDQ |
| Nov 21, 2018 | K181704 | Transpara Screenpoint Medical B.V., NL | QDQ |
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