FDA 510(k)

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

K-Number: K161163 · 2016-07-13

Decision Date2016-07-13

Product CodeLHN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi , Ltd.. It received FDA 510(k) clearance on 2016-07-13 under 510(k) 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. The listed applicant is Hitachi , Ltd.. The 510(k) number is K161163.

When did PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory receive FDA 510(k) clearance?

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

Who is the listed applicant for PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory?

The FDA 510(k) record lists Hitachi , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Hitachi , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LHN)

K260174PROBEAT-CRHitachi High-Tech Corp.K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.