uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
K-Number: K223028 · 2023-02-16
Decision Date2023-02-16
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2023-02-16 under approval number K223028. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the uCT ATLAS Astound with uWS-CT-Dual Energy Analysis?
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis is a medical device that received FDA 510(k) clearance on 2023-02-16. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K223028.
When was uCT ATLAS Astound with uWS-CT-Dual Energy Analysis approved by the FDA?
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis received FDA 510(k) clearance on 2023-02-16, under approval number K223028.
What company makes uCT ATLAS Astound with uWS-CT-Dual Energy Analysis?
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uCT ATLAS Astound with uWS-CT-Dual Energy Analysis?
The FDA product code for uCT ATLAS Astound with uWS-CT-Dual Energy Analysis is JAK.
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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.