Fetal EchoScan (v1.2)— 510(k) K252294

Substantially Equivalent

Brightheart

FDA 510(k) clearance K252294 for Fetal EchoScan (v1.2), Substantially Equivalent on 2025-12-08. Applicant: Brightheart.

Clearance details

Applicant: Brightheart
Product code: Code POK
Advisory panel: Radiology
Date received: 2025-07-23
Decision date: 2025-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

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