Devices · Shanghai United Imaging Healthcare Co., Ltd.

HYPER DLR

Shanghai United Imaging Healthcare Co., Ltd. is listed for HYPER DLR (K193210). The FDA list gives August 4, 2020 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is KPS. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K193210

Official FDA database record

Date of final decision

August 4, 2020

Company on the FDA list

Shanghai United Imaging Healthcare Co., Ltd.

Lead panel

Radiology

Primary product code

KPS

openFDA device name for the code

System, Tomography, Computed, Emission

Device class

2

Regulation number

892.1200

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary