ARC SERIES— 510(k) K954581

Substantially Equivalent

Continental X-Ray Corp.

FDA 510(k) clearance K954581 for ARC SERIES, Substantially Equivalent on 1995-12-21. Applicant: Continental X-Ray Corp..

Clearance details

Applicant: Continental X-Ray Corp.
Product code: Code IZI
Advisory panel: Radiology
Date received: 1995-10-02
Decision date: 1995-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broadview, IL, US

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Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.