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510(k) K181676

Mini Ridge Filter and auxiliary functions for PROBEAT-V by Hitachi Ltd. Healthcare Hitachi Works — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2018
Date Received
June 25, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Charged-Particle, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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