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FDA 510(k)

Real Time Image Gating System for Proton Beam Therapy Systems

K-Number: K171049 · 2017-12-26

ApplicantHitachi, Ltd. Healthcare
Decision Date2017-12-26
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Real Time Image Gating System for Proton Beam Therapy Systems is a medical device manufactured by Hitachi, Ltd. Healthcare. It received FDA 510(k) clearance on 2017-12-26 under approval number K171049. 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 Real Time Image Gating System for Proton Beam Therapy Systems?

Real Time Image Gating System for Proton Beam Therapy Systems is a medical device that received FDA 510(k) clearance on 2017-12-26. It is manufactured by Hitachi, Ltd. Healthcare. The 510(k) number is K171049.

When was Real Time Image Gating System for Proton Beam Therapy Systems approved by the FDA?

Real Time Image Gating System for Proton Beam Therapy Systems received FDA 510(k) clearance on 2017-12-26, under approval number K171049.

What company makes Real Time Image Gating System for Proton Beam Therapy Systems?

Real Time Image Gating System for Proton Beam Therapy Systems is manufactured by Hitachi, Ltd. Healthcare.

What is the FDA product code for Real Time Image Gating System for Proton Beam Therapy Systems?

The FDA product code for Real Time Image Gating System for Proton Beam Therapy Systems 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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