uCT ATLAS with uWS-CT-Dual Energy Analysis
K-Number: K203448 · 2021-08-11
Decision Date2021-08-11
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uCT ATLAS 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 2021-08-11 under approval number K203448. 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 with uWS-CT-Dual Energy Analysis?
uCT ATLAS with uWS-CT-Dual Energy Analysis is a medical device that received FDA 510(k) clearance on 2021-08-11. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K203448.
When was uCT ATLAS with uWS-CT-Dual Energy Analysis approved by the FDA?
uCT ATLAS with uWS-CT-Dual Energy Analysis received FDA 510(k) clearance on 2021-08-11, under approval number K203448.
What company makes uCT ATLAS with uWS-CT-Dual Energy Analysis?
uCT ATLAS with uWS-CT-Dual Energy Analysis is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uCT ATLAS with uWS-CT-Dual Energy Analysis?
The FDA product code for uCT ATLAS with uWS-CT-Dual Energy Analysis is JAK.
Related Clinical Trials
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.