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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 the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2026-04-23 under 510(k) 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. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K252815.

When did ProBeam 360 Proton Therapy System v3.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for ProBeam 360 Proton Therapy System v3.0?

The FDA 510(k) record lists Varian Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Varian Medical Systems, Inc. as applicant

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Related Devices (Code: LHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260174PROBEAT-CRHitachi High-Tech Corp.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.K232032PROBEAT-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

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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