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FDA 510(k)

Radiance 330 Proton Beam Therapy System

K-Number: K191521 · 2019-09-27

ApplicantProtom International Holding Corporation
Decision Date2019-09-27
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Radiance 330 Proton Beam Therapy System is a medical device manufactured by Protom International Holding Corporation. It received FDA 510(k) clearance on 2019-09-27 under approval number K191521. 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 Radiance 330 Proton Beam Therapy System?

Radiance 330 Proton Beam Therapy System is a medical device that received FDA 510(k) clearance on 2019-09-27. It is manufactured by Protom International Holding Corporation. The 510(k) number is K191521.

When was Radiance 330 Proton Beam Therapy System approved by the FDA?

Radiance 330 Proton Beam Therapy System received FDA 510(k) clearance on 2019-09-27, under approval number K191521.

What company makes Radiance 330 Proton Beam Therapy System?

Radiance 330 Proton Beam Therapy System is manufactured by Protom International Holding Corporation.

What is the FDA product code for Radiance 330 Proton Beam Therapy System?

The FDA product code for Radiance 330 Proton Beam 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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