EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS— 510(k) K962010

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K962010 for EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS, Substantially Equivalent on 1997-03-21. Applicant: Philips Medical Systems (Cleveland), Inc..

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1996-05-23
Decision date: 1997-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.