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FDA 510(k)

PROTON THERAPY MULTILEAF COLLIMATOR

K-Number: K093250 · 2009-12-24

ApplicantVarian Medical Systems
Decision Date2009-12-24
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROTON THERAPY MULTILEAF COLLIMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems. It received FDA 510(k) clearance on 2009-12-24 under 510(k) number K093250. 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 PROTON THERAPY MULTILEAF COLLIMATOR?

PROTON THERAPY MULTILEAF COLLIMATOR is a medical device that received FDA 510(k) clearance on 2009-12-24. The listed applicant is Varian Medical Systems. The 510(k) number is K093250.

When did PROTON THERAPY MULTILEAF COLLIMATOR receive FDA 510(k) clearance?

PROTON THERAPY MULTILEAF COLLIMATOR received FDA 510(k) clearance on 2009-12-24, under 510(k) number K093250.

Who is the listed applicant for PROTON THERAPY MULTILEAF COLLIMATOR?

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

What is the FDA product code for PROTON THERAPY MULTILEAF COLLIMATOR?

The FDA product code for PROTON THERAPY MULTILEAF COLLIMATOR is LHN.

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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.

K260597VIRTUE QAProNova SolutionsK260174PROBEAT-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.

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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