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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 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 2022-12-01 under 510(k) 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. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K221791.

When did ProBeam 360° Proton Therapy System receive FDA 510(k) clearance?

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

Who is the listed applicant for ProBeam 360° Proton Therapy System?

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?

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

Other records listing Varian Medical Systems, Inc. as applicant

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.

K261856Halcyon, Ethos Radiotherapy System (5.0)K261306AI Contouring (VA10A)K260750Virtual Cone (1.0)K253026Respiratory Gating for Scanners (2.1)K252717MAASTRO Rectal Applicator SetK252815ProBeam 360 Proton Therapy System v3.0

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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.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.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.

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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