PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory— 510(k) K161163

Name: FDA 510(k) clearance K161163
Creator: U.S. Food and Drug Administration
Published: 2016-07-13

Substantially Equivalent

Hitachi , Ltd.

FDA 510(k) clearance K161163 for PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory, Substantially Equivalent on 2016-07-13. Applicant: Hitachi , Ltd.. Device class: 2.

Clearance details

Applicant: Hitachi , Ltd.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2016-04-25
Decision date: 2016-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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