ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES— 510(k) K130842

Substantially Equivalent

Philips Medical Systems Nederland B.V.

FDA 510(k) clearance K130842 for ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES, Substantially Equivalent on 2013-05-21. Applicant: Philips Medical Systems Nederland B.V..

Clearance details

Applicant: Philips Medical Systems Nederland B.V.
Product code: Code IZI
Advisory panel: Radiology
Date received: 2013-03-27
Decision date: 2013-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Best Noord-Brabant, 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.