GammaBeam 500— 510(k) K150191

Substantially Equivalent

Best Theratronics Limited

FDA 510(k) clearance K150191 for GammaBeam 500, Substantially Equivalent on 2015-04-17. Applicant: Best Theratronics Limited. Device class: 2.

Clearance details

Applicant: Best Theratronics Limited
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2015-01-28
Decision date: 2015-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ottawa, CA

Download summary PDF View on FDA.gov ↗

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