OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM— 510(k) K012546

Substantially Equivalent

Sedecal USA, Inc.

FDA 510(k) clearance K012546 for OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM, Substantially Equivalent on 2001-11-02. Applicant: Sedecal USA, Inc..

Clearance details

Applicant: Sedecal USA, Inc.
Product code: Code KPR
Advisory panel: Radiology
Date received: 2001-08-07
Decision date: 2001-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.