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510(k) K260174

PROBEAT-CR by Hitachi High-Tech Corp. — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2026
Date Received
January 21, 2026
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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