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FDA 510(k)

PROTON THERAPY SYSTEM

K-Number: K062891 · 2006-12-14

ApplicantIndiana University Cyclotron Facility
Decision Date2006-12-14
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROTON THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Indiana University Cyclotron Facility. It received FDA 510(k) clearance on 2006-12-14 under 510(k) number K062891. 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 SYSTEM?

PROTON THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-14. The listed applicant is Indiana University Cyclotron Facility. The 510(k) number is K062891.

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

PROTON THERAPY SYSTEM received FDA 510(k) clearance on 2006-12-14, under 510(k) number K062891.

Who is the listed applicant for PROTON THERAPY SYSTEM?

The FDA 510(k) record lists Indiana University Cyclotron Facility as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTON THERAPY SYSTEM?

The FDA product code for PROTON THERAPY SYSTEM 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

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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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