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FDA 510(k)

PROBEAT

K-Number: K053280 · 2006-03-09

ApplicantHitachi, Ltd., Power Systems Group
Decision Date2006-03-09
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROBEAT is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi, Ltd., Power Systems Group. It received FDA 510(k) clearance on 2006-03-09 under 510(k) number K053280. 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?

PROBEAT is a medical device that received FDA 510(k) clearance on 2006-03-09. The listed applicant is Hitachi, Ltd., Power Systems Group. The 510(k) number is K053280.

When did PROBEAT receive FDA 510(k) clearance?

PROBEAT received FDA 510(k) clearance on 2006-03-09, under 510(k) number K053280.

Who is the listed applicant for PROBEAT?

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

What is the FDA product code for PROBEAT?

The FDA product code for PROBEAT is LHN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hitachi, Ltd., Power Systems Group 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.

K073059PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM

Related Devices (Code: LHN)

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.

K260597VIRTUE QAProNova SolutionsK260174PROBEAT-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.

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.

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