CAAS Workstation— 510(k) K151780

Substantially Equivalent

Pie Medical Imaging BV

FDA 510(k) clearance K151780 for CAAS Workstation, Substantially Equivalent on 2016-03-11. Applicant: Pie Medical Imaging BV.

Clearance details

Applicant: Pie Medical Imaging BV
Product code: Code IZI
Advisory panel: Radiology
Date received: 2015-07-01
Decision date: 2016-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maastricht, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.