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FDA 510(k)

McLaren Proton Therapy System

K-Number: K160063 · 2016-02-25

ApplicantMclaren Health Care Corporation
Decision Date2016-02-25
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

McLaren Proton Therapy System is a medical device manufactured by Mclaren Health Care Corporation. It received FDA 510(k) clearance on 2016-02-25 under approval number K160063. 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 McLaren Proton Therapy System?

McLaren Proton Therapy System is a medical device that received FDA 510(k) clearance on 2016-02-25. It is manufactured by Mclaren Health Care Corporation. The 510(k) number is K160063.

When was McLaren Proton Therapy System approved by the FDA?

McLaren Proton Therapy System received FDA 510(k) clearance on 2016-02-25, under approval number K160063.

What company makes McLaren Proton Therapy System?

McLaren Proton Therapy System is manufactured by Mclaren Health Care Corporation.

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

The FDA product code for McLaren 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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