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FDA 510(k)

PT2 VARIAN PROTON THERAPY SYSTEM

K-Number: K101294 · 2010-12-27

ApplicantVarian Medical Systems, Oncology Systems
Decision Date2010-12-27
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PT2 VARIAN PROTON THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Oncology Systems. It received FDA 510(k) clearance on 2010-12-27 under 510(k) number K101294. 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 PT2 VARIAN PROTON THERAPY SYSTEM?

PT2 VARIAN PROTON THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-27. The listed applicant is Varian Medical Systems, Oncology Systems. The 510(k) number is K101294.

When did PT2 VARIAN PROTON THERAPY SYSTEM receive FDA 510(k) clearance?

PT2 VARIAN PROTON THERAPY SYSTEM received FDA 510(k) clearance on 2010-12-27, under 510(k) number K101294.

Who is the listed applicant for PT2 VARIAN PROTON THERAPY SYSTEM?

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

What is the FDA product code for PT2 VARIAN PROTON THERAPY SYSTEM?

The FDA product code for PT2 VARIAN PROTON THERAPY SYSTEM is LHN.

Related Clinical Trials

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Other records listing Varian Medical Systems, Oncology Systems 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.

K123152VITESSE 3.0K103394BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)K101751VARIAN UNIQUE SINGLE ENERGY LINEAR ACCELERATOR

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

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

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