510(k) K254115
- Device
- ArteraAI Breast
- Applicant
- Artera, Inc.
- 510(k) number
- K254115
- Product code
- SHW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-04
- Date received
- 2025-12-19
- Regulation
- 864.3755
- Classification name
- Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Candice Bautista
- Address
- 108 1st St. Los Altos CA US 94022 94022
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code SHW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260023 | TumorSight Risk | SimBioSys, Inc. | 2026-09-25 |