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

Name: FDA 510(k) clearance K861994
Creator: U.S. Food and Drug Administration
Published: 1986-07-18

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.. Device class: 2.

Clearance details

Applicant: Medicor USA , Ltd.
Product code: Code KPR
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 1986-05-23
Decision date: 1986-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Medicor USA , Ltd.

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K861995 — MODEL RS-3 RADIOGRAPHIC STAND1986-06-19
K860025 — MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR1986-05-07
K850761 — MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C1985-09-19
K851358 — MODEL BION 2/TYPE 90 ROOM IONIZER1985-07-01
K851094 — MODEL BION 1/TYPE 1084T CAR IONIZER1985-06-19

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.