uDR 380i Pro
K-Number: K242515 · 2024-10-10
Decision Date2024-10-10
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uDR 380i Pro is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2024-10-10 under approval number K242515. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the uDR 380i Pro?
uDR 380i Pro is a medical device that received FDA 510(k) clearance on 2024-10-10. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K242515.
When was uDR 380i Pro approved by the FDA?
uDR 380i Pro received FDA 510(k) clearance on 2024-10-10, under approval number K242515.
What company makes uDR 380i Pro?
uDR 380i Pro is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uDR 380i Pro?
The FDA product code for uDR 380i Pro is IZL.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
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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.