CLINIX MP— 510(k) K960920

Substantially Equivalent

Philips Medical Systems (Cleveland), Inc.

FDA 510(k) clearance K960920 for CLINIX MP, Substantially Equivalent on 1996-05-20. Applicant: Philips Medical Systems (Cleveland), Inc..

Clearance details

Applicant: Philips Medical Systems (Cleveland), Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 1996-03-06
Decision date: 1996-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

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.