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FDA 510(k)

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory

K-Number: K161163 · 2016-07-13

ApplicantHitachi , Ltd.
Decision Date2016-07-13
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory is a medical device manufactured by Hitachi , Ltd.. It received FDA 510(k) clearance on 2016-07-13 under approval number K161163. 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 PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory?

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory is a medical device that received FDA 510(k) clearance on 2016-07-13. It is manufactured by Hitachi , Ltd.. The 510(k) number is K161163.

When was PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory approved by the FDA?

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory received FDA 510(k) clearance on 2016-07-13, under approval number K161163.

What company makes PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory?

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory is manufactured by Hitachi , Ltd..

What is the FDA product code for PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory?

The FDA product code for PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory is LHN.

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Other Devices by Hitachi , Ltd.

K162902ARIETTA Prologue Diagnostic Ultrasound system and Transducers K162583ALOKA LISENDO 880 K172087SANGRAY K163505ARIETTA PRECISION K191801PROBEAT-CR K201042PROBEAT-CR

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Related Devices (Code: LHN)

K162246ProNova SC360 Proton Therapy SystemPronova Solutions, LLC K160612Sumitomo Proton Therapy SystemSumitomo Heavy Industries, Ltd. K152224Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)Ion Beam Application S.A. K160432Anzai Respiratory Gating SystemAnzai Medical Co., Ltd. K153614PROBEAT-V and accessoriesHitachi, Ltd., Health Care Company K160063McLaren Proton Therapy SystemMclaren Health Care Corporation

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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