inHEART Models— 510(k) K231683

Substantially Equivalent

Inheart, Sas

FDA 510(k) clearance K231683 for inHEART Models, Substantially Equivalent on 2024-02-29. Applicant: Inheart, Sas. Device class: 2.

Clearance details

Applicant: Inheart, Sas
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2023-06-09
Decision date: 2024-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pessac, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code QIH

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

More clearances from Inheart, Sas

K220727 — inHEART MODELS2022-05-10

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