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510(k) K242515

uDR 380i Pro by Shanghai United Imaging Healthcare Co., Ltd. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2024
Date Received
August 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

Other clearances by Shanghai United Imaging Healthcare Co., Ltd.

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  • K251839 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (July 17, 2025)
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