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510(k) K252815

ProBeam 360 Proton Therapy System v3.0 by Varian Medical Systems, Inc. — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2026
Date Received
September 4, 2025
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 Varian Medical Systems, Inc.

  • K253026 — Respiratory Gating for Scanners (2.1) (June 4, 2026)
  • K252717 — MAASTRO Rectal Applicator Set (May 20, 2026)
  • K252304 — syngo.via RT Image Suite VC10 (March 18, 2026)
  • K252977 — Halcyon, Ethos Radiotherapy System (5.0) (January 21, 2026)
  • K252919 — IDENTIFY (5.0) (December 16, 2025)
  • K252884 — Guided Aarhus Applicator Set (November 19, 2025)
  • K252948 — TrueBeam, TrueBeam STX, Edge and VitalBeam (October 7, 2025)
  • K250099 — Mobius3D (4.1) (May 16, 2025)
  • K250299 — CT/ MR Tandem and Ovoid Set (May 9, 2025)
  • K250289 — Intracavitary/Interstitial System (April 25, 2025)

Other clearances for product code LHN

  • K260174 — PROBEAT-CR (June 11, 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)