Ingenia 1.5T CX and Ingenia 3.0T CX R5.3— 510(k) K162931

Substantially Equivalent

Philips Medical Systems Nederland B.V.

FDA 510(k) clearance K162931 for Ingenia 1.5T CX and Ingenia 3.0T CX R5.3, Substantially Equivalent on 2017-01-06. Applicant: Philips Medical Systems Nederland B.V..

Clearance details

Applicant: Philips Medical Systems Nederland B.V.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2016-10-19
Decision date: 2017-01-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Best, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

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.