uDR Arria & uDR Aris
K-Number: K252000 · 2025-11-26
Decision Date2025-11-26
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uDR Arria & uDR Aris is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-11-26 under approval number K252000. 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 Arria & uDR Aris?
uDR Arria & uDR Aris is a medical device that received FDA 510(k) clearance on 2025-11-26. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K252000.
When was uDR Arria & uDR Aris approved by the FDA?
uDR Arria & uDR Aris received FDA 510(k) clearance on 2025-11-26, under approval number K252000.
What company makes uDR Arria & uDR Aris?
uDR Arria & uDR Aris is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uDR Arria & uDR Aris?
The FDA product code for uDR Arria & uDR Aris is KPR.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.