uDR Aurora CX
K-Number: K251167 · 2025-09-19
Decision Date2025-09-19
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uDR Aurora CX is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-09-19 under approval number K251167. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the uDR Aurora CX?
uDR Aurora CX is a medical device that received FDA 510(k) clearance on 2025-09-19. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K251167.
When was uDR Aurora CX approved by the FDA?
uDR Aurora CX received FDA 510(k) clearance on 2025-09-19, under approval number K251167.
What company makes uDR Aurora CX?
uDR Aurora CX is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uDR Aurora CX?
The FDA product code for uDR Aurora CX is KPR.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
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Official Source
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