HYPER Focus— 510(k) K210418

Name: FDA 510(k) clearance K210418
Creator: U.S. Food and Drug Administration
Published: 2021-04-09

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K210418 for HYPER Focus, Substantially Equivalent on 2021-04-09. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai United Imaging Healthcare Co., Ltd.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2021-02-11
Decision date: 2021-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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