Fine Structure Analysis(fineSA)— 510(k) K150069

Substantially Equivalent

Acuitas Medical , Ltd.

FDA 510(k) clearance K150069 for Fine Structure Analysis(fineSA), Substantially Equivalent on 2015-05-22. Applicant: Acuitas Medical , Ltd..

Clearance details

Applicant: Acuitas Medical , Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2015-01-13
Decision date: 2015-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Swansea, GB

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.