KMC-950 C-ARM MOBILE SYSTEM— 510(k) K032761

Substantially Equivalent

United Radiology Systems, Inc.

FDA 510(k) clearance K032761 for KMC-950 C-ARM MOBILE SYSTEM, Substantially Equivalent on 2004-05-14. Applicant: United Radiology Systems, Inc..

Clearance details

Applicant: United Radiology Systems, Inc.
Product code: Code OWB
Advisory panel: Radiology
Date received: 2003-09-05
Decision date: 2004-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, US

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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.