Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QDQ — Predicate Candidate Screening
37 FDA 510(k) clearances under this product code; the 50 most recent screened below.
153 daysmedian FDA review time
269 days90th percentile
37clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260303 | See-Mode Augmented Reporting Tool, Breast (SMART-B) | See-Mode Technologies Pty, Ltd. | 2026-07-28 | 179 | 0 |
| K260714 | MammoScreen® (5) | Therapixel | 2026-06-26 | 113 | 0 |
| K253825 | Saige-Dx | DeepHealth, Inc. | 2026-06-15 | 196 | 0 |
| K253682 | DeepHealth ProstateAI | Quantib B.V. | 2026-04-29 | 159 | 0 |
| K260320 | Lunit INSIGHT MMG (v1.1.10) | Lunit, Inc. | 2026-04-23 | 83 | 0 |
| K253796 | Lunit INSIGHT DBT (V1.2) | Lunit, Inc. | 2026-03-26 | 118 | 0 |
| K251474 | Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies | 2026-02-06 | 269 | 0 |
| K251873 | Saige-Dx | DeepHealth, Inc. | 2025-08-11 | 54 | 0 |
| K243341 | Genius AI Detection 2.0 | Hologic, Inc. | 2025-07-31 | 279 | 0 |
| K243679 | MammoScreen® (4) | Therapixel | 2025-07-03 | 216 | 0 |
| K242683 | QP-Prostate® CAD | Quibim S.L. | 2025-03-18 | 193 | 0 |
| K241770 | Prostate MR AI (VA10A) | Siemens Healthcare GmbH | 2025-03-05 | 258 | 0 |
| K243688 | Saige-Dx (3.1.0) | DeepHealth, Inc. | 2024-12-19 | 20 | 0 |
| K241831 | Transpara (2.1.0) | Screenpoint Medical B.V. | 2024-11-25 | 153 | 0 |
| K241747 | Saige-Dx | DeepHealth, Inc. | 2024-11-18 | 153 | 0 |
| K240417 | ProFound Detection (V4.0) | Icad, Inc. | 2024-11-08 | 269 | 0 |
| K242652 | Lunit INSIGHT DBT v1.1 | Lunit, Inc. | 2024-10-04 | 30 | 0 |
| K240697 | See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | See-Mode Technologies Pte, Ltd. | 2024-09-09 | 179 | 0 |
| K240301 | MammoScreen® (3) | Therapixel | 2024-08-01 | 182 | 0 |
| K231470 | Lunit INSIGHT DBT | Lunit, Inc. | 2023-11-06 | 168 | 0 |
| K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. | 2023-05-23 | 130 | 0 |
| K221449 | Genius AI Detection 2.0 | Hologic, Inc. | 2022-10-06 | 141 | 0 |
| K221347 | Transpara 1.7.2 | Screenpoint Medical B.V. | 2022-08-03 | 86 | 0 |
| K212783 | ProstatID | Scanmed, LLC | 2022-07-08 | 310 | 0 |
| K220105 | Saige-Dx | DeepHealth, Inc. | 2022-05-12 | 120 | 0 |
| K210670 | BU-CAD | Taihao Medical, Inc. | 2021-12-21 | 291 | 0 |
| K211541 | MammoScreen 2.0 | Therapixel | 2021-11-26 | 191 | 0 |
| K211678 | Lunit INSIGHT MMG | Lunit, Inc. | 2021-11-17 | 169 | 0 |
| K210404 | Transpara 1.7.0 | Screenpoint Medical B.V. | 2021-06-02 | 112 | 0 |
| K203822 | ProFound AI Software V3.0 | Icad, Inc. | 2021-03-12 | 73 | 0 |
| K201019 | Genius AI Detection | Hologic, Inc. | 2020-11-18 | 215 | 0 |
| K192854 | MammoScreen | Therapixel | 2020-03-25 | 173 | 0 |
| K193229 | Transpara | Screenpoint Medical B.V. | 2020-03-05 | 104 | 0 |
| K192287 | Transpara | Screenpoint Medical B.V. | 2019-12-10 | 110 | 0 |
| K191994 | ProFound AI Software V2.1 | Icad, Inc. | 2019-10-04 | 70 | 0 |
| K182373 | PowerLook Tomo Detection V2 Software | Icad, Inc. | 2018-12-06 | 97 | 0 |
| K181704 | Transpara | Screenpoint Medical B.V. | 2018-11-21 | 147 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda