PHILIPS MODEL MX 16 SLICE CT SYSTEM— 510(k) K083498

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K083498 for PHILIPS MODEL MX 16 SLICE CT SYSTEM, Substantially Equivalent on 2008-12-17. Applicant: Philips Medical Systems (Cleveland), Inc..

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2008-11-25
Decision date: 2008-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

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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.