OSIRIX MD— 510(k) K101342

Substantially Equivalent

Pixmeo Sarl

FDA 510(k) clearance K101342 for OSIRIX MD, Substantially Equivalent on 2010-08-20. Applicant: Pixmeo Sarl.

Clearance details

Applicant: Pixmeo Sarl
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2010-05-13
Decision date: 2010-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denton, TX, US

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.