ArteraAI Breast— 510(k) K254115
Substantially EquivalentArtera, Inc.
FDA 510(k) clearance K254115 for ArteraAI Breast, Substantially Equivalent on 2026-05-04. Applicant: Artera, Inc.. Device class: 2.
Clearance details
- Applicant
- Artera, Inc.
- Product code
- Code SHW
- Device class
- Class 2
- Regulation
- 21 CFR 864.3755
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Altos, CA, US
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