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. Device class: 2.

Clearance details

Applicant: Brightheart
Product code: Code POK
Device class: Class 2
Regulation: 21 CFR 892.2060
Advisory panel: Radiology
Date received: 2025-07-23
Decision date: 2025-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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More clearances from Brightheart

K251456 — BrightHeart View Classifier2025-06-05
K243684 — BrightHeart View Classifier2025-05-07
K251071 — Fetal EchoScan (v1.1)2025-05-02
K242342 — Fetal EchoScan2024-11-14

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