FDA Product Code
FDA Product Code SHW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Pathology
- 21 CFR Citation
- 864.3755
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260023 | TumorSight Risk | SimBioSys, Inc. | 2026-09-25 | Traditional | PDF ↗ |
| K254115 | ArteraAI Breast | Artera, Inc. | 2026-05-04 | Traditional | PDF ↗ |
Product code SHW · Class II · Pathology. Data: openFDA.