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510(k) K260174

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

K260174 is an FDA 510(k) premarket notification submitted by Hitachi High-Tech Corp. for the device "PROBEAT-CR". The FDA issued a decision of Substantially Equivalent on June 11, 2026. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050.

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

Other clearances for product code LHN

  • K252815 — ProBeam 360 Proton Therapy System v3.0 (April 23, 2026)
  • K253406 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (March 25, 2026)
  • K250986 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (September 12, 2025)
  • 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)

FDA data resources