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510(k) K201042

PROBEAT-CR by Hitachi , Ltd. — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2020
Date Received
April 20, 2020
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.

  • K191801 — PROBEAT-CR (September 13, 2019)
  • K172087 — SANGRAY (October 27, 2017)
  • K163505 — ARIETTA PRECISION (May 30, 2017)
  • K162902 — ARIETTA Prologue Diagnostic Ultrasound system and Transducers (December 15, 2016)
  • K162583 — ALOKA LISENDO 880 (November 17, 2016)
  • K161163 — PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory (July 13, 2016)
  • K060834 — PROBEAT WITH MGCS (April 19, 2006)

Other clearances for product code LHN

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  • K243900 — eMotus Respiratory Motion Management System (June 27, 2025)
  • K242418 — P-Cure Proton Therapy System (PPTS) (May 12, 2025)
  • K232032 — PROBEAT-FR (January 12, 2024)
  • K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom) (October 6, 2023)
  • K221996 — P-Cure Proton Beam Therapy System (March 20, 2023)
  • K220883 — Small Field Applicator (December 15, 2022)
  • K221791 — ProBeam 360° Proton Therapy System (December 1, 2022)
  • K201798 — myQA iON (July 17, 2020)
  • K200282 — Orfit Aerial Couchtop (April 8, 2020)