MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM— 510(k) K861994

Substantially Equivalent

Medicor USA , Ltd.

FDA 510(k) clearance K861994 for MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM, Substantially Equivalent on 1986-07-18. Applicant: Medicor USA , Ltd..

Clearance details

Applicant: Medicor USA , Ltd.
Product code: Code KPR
Advisory panel: Radiology
Date received: 1986-05-23
Decision date: 1986-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, 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.