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FDA 510(k)

SUMITOMO PROTON THERAPY SYSTEM

K-Number: K130426 · 2013-11-19

ApplicantSumitomo Heavy Industries, Ltd.
Decision Date2013-11-19
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SUMITOMO PROTON THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sumitomo Heavy Industries, Ltd.. It received FDA 510(k) clearance on 2013-11-19 under 510(k) number K130426. 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 SUMITOMO PROTON THERAPY SYSTEM?

SUMITOMO PROTON THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-19. The listed applicant is Sumitomo Heavy Industries, Ltd.. The 510(k) number is K130426.

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

SUMITOMO PROTON THERAPY SYSTEM received FDA 510(k) clearance on 2013-11-19, under 510(k) number K130426.

Who is the listed applicant for SUMITOMO PROTON THERAPY SYSTEM?

The FDA 510(k) record lists Sumitomo Heavy Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUMITOMO PROTON THERAPY SYSTEM?

The FDA product code for SUMITOMO PROTON THERAPY SYSTEM is LHN.

Related Clinical Trials

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Other records listing Sumitomo Heavy Industries, Ltd. 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.

K160612Sumitomo Proton Therapy System

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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