RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM— 510(k) K860606

Name: FDA 510(k) clearance K860606
Creator: U.S. Food and Drug Administration
Published: 1986-03-20

Substantially Equivalent

Bionix Corp.

FDA 510(k) clearance K860606 for RADIACARE INTRAOPERATIVE RADIOTHERAPY SYSTEM, Substantially Equivalent on 1986-03-20. Applicant: Bionix Corp.. Device class: 2.

Clearance details

Applicant: Bionix Corp.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 1986-02-19
Decision date: 1986-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holland, OH, US

Download summary PDF View on FDA.gov ↗

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