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FDA 510(k)

Sumitomo Proton Therapy System

K-Number: K160612 · 2016-08-17

ApplicantSumitomo Heavy Industries, Ltd.
Decision Date2016-08-17
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sumitomo Proton Therapy System is a medical device manufactured by Sumitomo Heavy Industries, Ltd.. It received FDA 510(k) clearance on 2016-08-17 under approval number K160612. 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 2016-08-17. It is manufactured by Sumitomo Heavy Industries, Ltd.. The 510(k) number is K160612.

When was Sumitomo Proton Therapy System approved by the FDA?

Sumitomo Proton Therapy System received FDA 510(k) clearance on 2016-08-17, under approval number K160612.

What company makes Sumitomo Proton Therapy System?

Sumitomo Proton Therapy System is manufactured by Sumitomo Heavy Industries, Ltd..

What is the FDA product code for Sumitomo Proton Therapy System?

The FDA product code for Sumitomo Proton Therapy System is LHN.

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Related PubMed Literature

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Related Devices (Code: LHN)

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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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