CAAS QCA 3D— 510(k) K063344

Substantially Equivalent

Pie Medical Imaging BV

FDA 510(k) clearance K063344 for CAAS QCA 3D, Substantially Equivalent on 2006-11-28. Applicant: Pie Medical Imaging BV.

Clearance details

Applicant: Pie Medical Imaging BV
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2006-11-06
Decision date: 2006-11-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Maastricht, NL

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.