PROBEAT-CR— 510(k) K201042

Substantially Equivalent

Hitachi , Ltd.

FDA 510(k) clearance K201042 for PROBEAT-CR, Substantially Equivalent on 2020-07-13. Applicant: Hitachi , Ltd..

Clearance details

Applicant: Hitachi , Ltd.
Product code: Code LHN
Advisory panel: Radiology
Date received: 2020-04-20
Decision date: 2020-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kashiwa-Shi, JP

Download summary PDF View on FDA.gov ↗

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