K171049

Substantially Equivalent

Real Time Image Gating System for Proton Beam Therapy Systems

Applicant: Hitachi, Ltd. Healthcare
Product code: LHN
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 ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.