Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
Regulation 864.3755
2510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SHW
| Company | 510(k)s | Recalls |
|---|---|---|
| Artera, Inc. | 1 | 0 |
| SimBioSys, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 2026 | K260023 | TumorSight Risk SimBioSys, Inc. | SHW |
| May 4, 2026 | K254115 | ArteraAI Breast Artera, Inc. | SHW |
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