OptimMRI (v2)— 510(k) K242054

Substantially Equivalent

Rebrain, Sas

FDA 510(k) clearance K242054 for OptimMRI (v2), Substantially Equivalent on 2024-08-12. Applicant: Rebrain, Sas. Device class: 2.

Clearance details

Applicant: Rebrain, Sas
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-07-15
Decision date: 2024-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Pessac, 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 Rebrain, Sas

K230150 — OptimMRI2023-07-21

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