Allura Xper FD series and Allura Xper OR Table series— 510(k) K162859

Substantially Equivalent

Philips Medical Systems Nederland B.V.

FDA 510(k) clearance K162859 for Allura Xper FD series and Allura Xper OR Table series, Substantially Equivalent on 2016-12-02. Applicant: Philips Medical Systems Nederland B.V..

Clearance details

Applicant: Philips Medical Systems Nederland B.V.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2016-10-12
Decision date: 2016-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Best Noord-Brabant, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.