HYPER DLR— 510(k) K193210

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K193210 for HYPER DLR, Substantially Equivalent on 2020-08-04. Applicant: Shanghai United Imaging Healthcare Co., Ltd..

Clearance details

Applicant: Shanghai United Imaging Healthcare Co., Ltd.
Product code: Code KPS
Advisory panel: Radiology
Date received: 2019-11-21
Decision date: 2020-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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