BrightHeart View Classifier— 510(k) K251456

Substantially Equivalent

Brightheart

FDA 510(k) clearance K251456 for BrightHeart View Classifier, Substantially Equivalent on 2025-06-05. Applicant: Brightheart. Device class: 2.

Clearance details

Applicant: Brightheart
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-05-12
Decision date: 2025-06-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

K260879 — 4DM2026-09-10
K261795 — Quicktome Software Suite2026-09-10
K251417 — ReVISION 22026-09-09
K260525 — NextMR Spine2026-09-04
K260811 — Heartvue.Proton2026-08-26

More clearances from Brightheart

K252294 — Fetal EchoScan (v1.2)2025-12-08
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.