MR DWI/FLAIR Measurement V1.0— 510(k) K230552

Substantially Equivalent

Olea Medical

FDA 510(k) clearance K230552 for MR DWI/FLAIR Measurement V1.0, Substantially Equivalent on 2023-04-26. Applicant: Olea Medical.

Clearance details

Applicant: Olea Medical
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2023-02-28
Decision date: 2023-04-26
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.