OptimMRI— 510(k) K230150

Substantially Equivalent

Rebrain, Sas

FDA 510(k) clearance K230150 for OptimMRI, Substantially Equivalent on 2023-07-21. 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: 2023-01-19
Decision date: 2023-07-21
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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K260811 — Heartvue.Proton2026-08-26

More clearances from Rebrain, Sas

K242054 — OptimMRI (v2)2024-08-12

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