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FDA 510(k)

PROBEAT-CR

K-Number: K260174 · 2026-06-11

ApplicantHitachi High-Tech Corp.
Decision Date2026-06-11
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROBEAT-CR is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi High-Tech Corp.. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K260174. 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-CR?

PROBEAT-CR is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Hitachi High-Tech Corp.. The 510(k) number is K260174.

When did PROBEAT-CR receive FDA 510(k) clearance?

PROBEAT-CR received FDA 510(k) clearance on 2026-06-11, under 510(k) number K260174.

Who is the listed applicant for PROBEAT-CR?

The FDA 510(k) record lists Hitachi High-Tech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROBEAT-CR?

The FDA product code for PROBEAT-CR is LHN.

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.

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.K232032PROBEAT-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

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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