Clearance Summary
breastscape v1.0 received FDA 510(k) clearance under submission number K211431, sponsored by Olea Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-08-02.
- Submission: K211431
- Applicant / Sponsor: Olea Medical
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2021-08-02
Classification & Regulation
This clearance is catalogued under FDA product code QIH and 21 CFR 892.2050, within the Radiology review panel as a Class II device.