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510(k) K220883

Small Field Applicator by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2022
Date Received
March 25, 2022
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

Other clearances by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

  • K232032 — PROBEAT-FR (January 12, 2024)

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