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FDA 510(k)

ProBeam 360° Proton Therapy System

K-Number: K221791 · 2022-12-01

ApplicantVarian Medical Systems, Inc.
Decision Date2022-12-01
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ProBeam 360° Proton Therapy System is a medical device manufactured by Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-12-01 under approval number K221791. 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?

ProBeam 360° Proton Therapy System is a medical device that received FDA 510(k) clearance on 2022-12-01. It is manufactured by Varian Medical Systems, Inc.. The 510(k) number is K221791.

When was ProBeam 360° Proton Therapy System approved by the FDA?

ProBeam 360° Proton Therapy System received FDA 510(k) clearance on 2022-12-01, under approval number K221791.

What company makes ProBeam 360° Proton Therapy System?

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

What is the FDA product code for ProBeam 360° Proton Therapy System?

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

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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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