Fetal EchoScan (v1.1)— 510(k) K251071

Substantially Equivalent

Brightheart

FDA 510(k) clearance K251071 for Fetal EchoScan (v1.1), Substantially Equivalent on 2025-05-02. Applicant: Brightheart.

Clearance details

Applicant: Brightheart
Product code: Code POK
Advisory panel: Radiology
Date received: 2025-04-07
Decision date: 2025-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Paris, FR

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