Allura Xper R9— 510(k) K162148

Substantially Equivalent

Philips Medical Systems Nethrlands BV

FDA 510(k) clearance K162148 for Allura Xper R9, Substantially Equivalent on 2016-11-23. Applicant: Philips Medical Systems Nethrlands BV.

Clearance details

Applicant: Philips Medical Systems Nethrlands BV
Product code: Code OWB
Advisory panel: Radiology
Date received: 2016-08-01
Decision date: 2016-11-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
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.