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.

Clearance details

Applicant: Rebrain, Sas
Product code: Code QIH
Advisory panel: Radiology
Date received: 2024-07-15
Decision date: 2024-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Pessac, FR

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