PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL— 510(k) K092747

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K092747 for PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL, Substantially Equivalent on 2009-10-09. Applicant: Philips Medical Systems (Cleveland), Inc..

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2009-09-08
Decision date: 2009-10-09
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.