RADIANCE 330 PROTON THERAPY SYSTEM— 510(k) K134052

Name: FDA 510(k) clearance K134052
Creator: U.S. Food and Drug Administration
Published: 2014-03-14

Substantially Equivalent

Protom International, Inc.

FDA 510(k) clearance K134052 for RADIANCE 330 PROTON THERAPY SYSTEM, Substantially Equivalent on 2014-03-14. Applicant: Protom International, Inc.. Device class: 2.

Clearance details

Applicant: Protom International, Inc.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2013-12-31
Decision date: 2014-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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