PROBEAT-CR— 510(k) K260174

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.

Clearance details

Applicant: Hitachi High-Tech Corp.
Product code: 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.