uMI 550 PET/CT System— 510(k) K182237

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K182237 for uMI 550 PET/CT System, Substantially Equivalent on 2018-10-12. 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: 2018-08-17
Decision date: 2018-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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