breastscape v1.0— 510(k) K211431

Substantially Equivalent

Olea Medical

FDA 510(k) clearance K211431 for breastscape v1.0, Substantially Equivalent on 2021-08-02. Applicant: Olea Medical. Device class: 2.

Clearance details

Applicant: Olea Medical
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-05-07
Decision date: 2021-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Ciotat, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.