Class Class II

uDR Aurora CX (K251167)

K251167 2025-09-19 Traditional
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Description

uDR Aurora CX by Shanghai United Imaging Healthcare Co., Ltd., an FDA 510(k) cleared radiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251167
Clearance Date2025-09-19
Clearance TypeTraditional
Product CodeKPR
Regulation Number892.1680

Categories

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