Philips Multislice CT System with Low Dose CT Lung Cancer— 510(k) K153444

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K153444 for Philips Multislice CT System with Low Dose CT Lung Cancer, Substantially Equivalent on 2016-04-08. Applicant: Philips Medical Systems (Cleveland), Inc..

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2015-11-27
Decision date: 2016-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.