ArteraAI Breast
FDA 510(k) clearance K254115 · decided 2026-05-04
Clearance details
- K-number
- K254115
- Device name
- ArteraAI Breast
- Applicant
- Artera, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-19
- Decision date
- 2026-05-04
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- SHW
- Device class
- 2
- Regulation number
- 864.3755
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Los Altos, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.