Brightheart

Brightheart holds 5 FDA 510(k) medical device clearances, first cleared 2024, most recent 2025.

Top product codes for Brightheart

POK — Radiology3 devices
QIH — Radiology2 devices

Recent clearances by Brightheart

K252294 — Fetal EchoScan (v1.2)Code POK·2025-12-08
K251456 — BrightHeart View ClassifierCode QIH·2025-06-05
K243684 — BrightHeart View ClassifierCode QIH·2025-05-07
K251071 — Fetal EchoScan (v1.1)Code POK·2025-05-02
K242342 — Fetal EchoScanCode POK·2024-11-14

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