SUMITOMO PROTON THERAPY SYSTEM— 510(k) K130426

Name: FDA 510(k) clearance K130426
Creator: U.S. Food and Drug Administration
Published: 2013-11-19

Substantially Equivalent

Sumitomo Heavy Industries, Ltd.

FDA 510(k) clearance K130426 for SUMITOMO PROTON THERAPY SYSTEM, Substantially Equivalent on 2013-11-19. Applicant: Sumitomo Heavy Industries, Ltd.. Device class: 2.

Clearance details

Applicant: Sumitomo Heavy Industries, Ltd.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2013-02-20
Decision date: 2013-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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