PROBEAT-CR— 510(k) K260174

Name: FDA 510(k) clearance K260174
Creator: U.S. Food and Drug Administration
Published: 2026-06-11

Substantially Equivalent

Hitachi High-Tech Corp.

FDA 510(k) clearance K260174 for PROBEAT-CR, Substantially Equivalent on 2026-06-11. Applicant: Hitachi High-Tech Corp.. Device class: 2.

Summary

Hitachi High-Tech's PROBEAT-CR is filed under LHN, medical charged-particle radiation therapy systems. The record doesn't expand "CR" or describe the system beyond the code name.

Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).

Hitachi High-Tech filed from Kashiwa-Shi, Japan. Review took 141 calendar days (January 21 to June 11, 2026).

Clearance details

Applicant: Hitachi High-Tech Corp.
Product code: Product code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2026-01-21
Decision date: 2026-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kashiwa-Shi, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.