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FDA 510(k)

ProBeam 360 Proton Therapy System v3.0

K-Number: K252815 · 2026-04-23

ApplicantVarian Medical Systems, Inc.
Decision Date2026-04-23
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ProBeam 360 Proton Therapy System v3.0 is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-04-23 under approval number K252815. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProBeam 360 Proton Therapy System v3.0?

ProBeam 360 Proton Therapy System v3.0 is a medical device that received FDA 510(k) clearance on 2026-04-23. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K252815.

When was ProBeam 360 Proton Therapy System v3.0 approved by the FDA?

ProBeam 360 Proton Therapy System v3.0 received FDA 510(k) clearance on 2026-04-23, under approval number K252815.

What company makes ProBeam 360 Proton Therapy System v3.0?

ProBeam 360 Proton Therapy System v3.0 is manufactured by Varian Medical Systems, Inc..

What is the FDA product code for ProBeam 360 Proton Therapy System v3.0?

The FDA product code for ProBeam 360 Proton Therapy System v3.0 is LHN.

Related Clinical Trials

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Related PubMed Literature

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Related Devices (Code: LHN)

K162246ProNova SC360 Proton Therapy SystemPronova Solutions, LLC K160612Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd. K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. K161163PROBEAT-V Proton Beam Therapy System with X-ray Limiting AccessoryHitachi , Ltd. K160432Anzai Respiratory Gating SystemAnzai Medical Co., Ltd. K153614PROBEAT-V and accessoriesHitachi, Ltd., Health Care Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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