Functional MR V1.0— 510(k) K221426

Substantially Equivalent

Olea Medical S.A.S.

FDA 510(k) clearance K221426 for Functional MR V1.0, Substantially Equivalent on 2022-07-06. Applicant: Olea Medical S.A.S..

Clearance details

Applicant: Olea Medical S.A.S.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2022-05-16
Decision date: 2022-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Ciotat, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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