Real Time Image Gating System for Proton Beam Therapy Systems— 510(k) K171049

Name: FDA 510(k) clearance K171049
Creator: U.S. Food and Drug Administration
Published: 2017-12-26

Substantially Equivalent

Hitachi, Ltd. Healthcare

FDA 510(k) clearance K171049 for Real Time Image Gating System for Proton Beam Therapy Systems, Substantially Equivalent on 2017-12-26. Applicant: Hitachi, Ltd. Healthcare. Device class: 2.

Clearance details

Applicant: Hitachi, Ltd. Healthcare
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2017-04-07
Decision date: 2017-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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