COMPACS, VERSION 1.0— 510(k) K041581

Substantially Equivalent

Intelligent Images Srl

FDA 510(k) clearance K041581 for COMPACS, VERSION 1.0, Substantially Equivalent on 2004-06-22. Applicant: Intelligent Images Srl.

Clearance details

Applicant: Intelligent Images Srl
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2004-06-14
Decision date: 2004-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Genova (Ge), IT

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.