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510(k) Data Aggregation
K Number
K152207Device Name
Extended Range Shifter for PROBEAT-V
Manufacturer
Hitachi,Ltd. , Health Care Company
Date Cleared
2015-10-02
(57 days)
Product Code
LHN
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
Hitachi,Ltd. , Health Care Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Extended Range Shifter is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
Device Description
This accessory is added to the nozzle of the cleared PROBEAT-V to suppress the beam spreading further compared to use of the standard range shifter.
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