Sumitomo Proton Therapy System— 510(k) K160612

Substantially Equivalent

Sumitomo Heavy Industries, Ltd.

FDA 510(k) clearance K160612 for Sumitomo Proton Therapy System, Substantially Equivalent on 2016-08-17. Applicant: Sumitomo Heavy Industries, Ltd..

Clearance details

Applicant: Sumitomo Heavy Industries, Ltd.
Product code: Code LHN
Advisory panel: Radiology
Date received: 2016-03-03
Decision date: 2016-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niihama, JP

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