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FDA 510(k)

PROBEAT WITH MGCS

K-Number: K060834 · 2006-04-19

ApplicantHitachi , Ltd.
Decision Date2006-04-19
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROBEAT WITH MGCS is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi , Ltd.. It received FDA 510(k) clearance on 2006-04-19 under 510(k) number K060834. 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 WITH MGCS?

PROBEAT WITH MGCS is a medical device that received FDA 510(k) clearance on 2006-04-19. The listed applicant is Hitachi , Ltd.. The 510(k) number is K060834.

When did PROBEAT WITH MGCS receive FDA 510(k) clearance?

PROBEAT WITH MGCS received FDA 510(k) clearance on 2006-04-19, under 510(k) number K060834.

Who is the listed applicant for PROBEAT WITH MGCS?

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 WITH MGCS?

The FDA product code for PROBEAT WITH MGCS is LHN.

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Other records listing Hitachi , Ltd. as applicant

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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

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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