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. 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: 2025-04-07
Decision date: 2025-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code POK

K253884 — Koios DS (3.8)2026-07-02
K261519 — Sonio Suspect2026-06-04
K254161 — Automated Aortic Stenosis Software (AutoAS)2026-03-27
K251769 — RevealAI-Lung2026-01-30
K252294 — Fetal EchoScan (v1.2)2025-12-08

More clearances from Brightheart

K251456 — BrightHeart View Classifier2025-06-05
K243684 — BrightHeart View Classifier2025-05-07
K242342 — Fetal EchoScan2024-11-14

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