AI Cancer Detection Software for Radiology
Marks places on a scan that may be cancer, and in some cases gives a score for how suspicious they look.
This is a bigger claim than triage, and the bar is correspondingly higher.
These products point at a specific place on the image and say look here. Some go further and attach a score for how suspicious the spot appears. Mammography is the best known use, but the same device type covers lung and other cancers.
The honest framing is a second pair of eyes that never gets tired and never gets bored, attached to a colleague who never gets to make the final call. The radiologist signs the report.
Two failure shapes matter. A mark on something harmless costs a patient a callback, extra imaging, and a bad fortnight. A missed mark costs far more. Any vendor worth talking to will show you both numbers without being pushed.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- QDQ
- FDA name for it
- Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- Rule number
- 21 CFR 892.2090
- Risk class
- Class 2
- Medical field
- Radiology
Before You Sign Anything
- Ask for the false positive rate per study, not per lesion. Per study is the number your patients experience.
- Ask whether the reading room saw the marks before or after forming an opinion. Concurrent and second-read setups produce genuinely different results.
- Ask how it performs on dense breast tissue, or the equivalent hard case in your use. Average accuracy hides the cases you bought it for.
- Ask what the retraining schedule is and how you will be told. A model that changes after purchase is a real event, not a footnote.
Who Holds the Most Clearances Here
| Company | Cleared products |
|---|---|
| Screenpoint Medical B.V. | 7 |
| Therapixel | 5 |
| DeepHealth, Inc. | 5 |
| Lunit, Inc. | 5 |
| Hologic, Inc. | 4 |
| Icad, Inc. | 4 |
| BeamWorks, Inc. | 1 |
| See-Mode Technologies Pty, Ltd. | 1 |
Every Cleared Product, Newest First
Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| Transpara (2.1.0) | Screenpoint Medical B.V. | August 14, 2026 | K260898 |
| CadAI-B Dx | BeamWorks, Inc. | August 12, 2026 | K260086 |
| See-Mode Augmented Reporting Tool, Breast (SMART-B) | See-Mode Technologies Pty, Ltd. | July 28, 2026 | K260303 |
| MammoScreen® (5) | Therapixel | June 26, 2026 | K260714 |
| Saige-Dx | DeepHealth, Inc. | June 15, 2026 | K253825 |
| DeepHealth ProstateAI | Quantib B.V. | April 29, 2026 | K253682 |
| Lunit INSIGHT MMG (v1.1.10) | Lunit, Inc. | April 23, 2026 | K260320 |
| Lunit INSIGHT DBT (V1.2) | Lunit, Inc. | March 26, 2026 | K253796 |
| Median LCS (internal name) / eyonis LCS (trade name) (1.0) | Median Technologies | February 6, 2026 | K251474 |
| Saige-Dx | DeepHealth, Inc. | August 11, 2025 | K251873 |
| Genius AI Detection 2.0 | Hologic, Inc. | July 31, 2025 | K243341 |
| MammoScreen® (4) | Therapixel | July 3, 2025 | K243679 |
| QP-Prostate® CAD | Quibim S.L. | March 18, 2025 | K242683 |
| Prostate MR AI (VA10A) | Siemens Healthcare GmbH | March 5, 2025 | K241770 |
| Saige-Dx (3.1.0) | DeepHealth, Inc. | December 19, 2024 | K243688 |
| Transpara (2.1.0) | Screenpoint Medical B.V. | November 25, 2024 | K241831 |
| Saige-Dx | DeepHealth, Inc. | November 18, 2024 | K241747 |
| ProFound Detection (V4.0) | Icad, Inc. | November 8, 2024 | K240417 |
| Lunit INSIGHT DBT v1.1 | Lunit, Inc. | October 4, 2024 | K242652 |
| See-Mode Augmented Reporting Tool, Thyroid (SMART-T) | See-Mode Technologies Pte, Ltd. | September 9, 2024 | K240697 |
| MammoScreen® (3) | Therapixel | August 1, 2024 | K240301 |
| Lunit INSIGHT DBT | Lunit, Inc. | November 6, 2023 | K231470 |
| Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. | May 23, 2023 | K230096 |
| Genius AI Detection 2.0 | Hologic, Inc. | October 6, 2022 | K221449 |
| Transpara 1.7.2 | Screenpoint Medical B.V. | August 3, 2022 | K221347 |
| ProstatID | Scanmed, LLC | July 8, 2022 | K212783 |
| Saige-Dx | DeepHealth, Inc. | May 12, 2022 | K220105 |
| BU-CAD | Taihao Medical, Inc. | December 21, 2021 | K210670 |
| MammoScreen 2.0 | Therapixel | November 26, 2021 | K211541 |
| Lunit INSIGHT MMG | Lunit, Inc. | November 17, 2021 | K211678 |
| Transpara 1.7.0 | Screenpoint Medical B.V. | June 2, 2021 | K210404 |
| ProFound AI Software V3.0 | Icad, Inc. | March 12, 2021 | K203822 |
| Genius AI Detection | Hologic, Inc. | November 18, 2020 | K201019 |
| MammoScreen | Therapixel | March 25, 2020 | K192854 |
| Transpara | Screenpoint Medical B.V. | March 5, 2020 | K193229 |
| Transpara | Screenpoint Medical B.V. | December 10, 2019 | K192287 |
| ProFound AI Software V2.1 | Icad, Inc. | October 4, 2019 | K191994 |
| PowerLook Tomo Detection V2 Software | Icad, Inc. | December 6, 2018 | K182373 |
| Transpara | Screenpoint Medical B.V. | November 21, 2018 | K181704 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.