uCT 780 with uWS-CT-Dual Energy Analysis
K-Number: K253173 · 2026-01-20
Decision Date2026-01-20
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uCT 780 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 2026-01-20 under approval number K253173. 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 780 with uWS-CT-Dual Energy Analysis?
uCT 780 with uWS-CT-Dual Energy Analysis is a medical device that received FDA 510(k) clearance on 2026-01-20. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K253173.
When was uCT 780 with uWS-CT-Dual Energy Analysis approved by the FDA?
uCT 780 with uWS-CT-Dual Energy Analysis received FDA 510(k) clearance on 2026-01-20, under approval number K253173.
What company makes uCT 780 with uWS-CT-Dual Energy Analysis?
uCT 780 with uWS-CT-Dual Energy Analysis is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uCT 780 with uWS-CT-Dual Energy Analysis?
The FDA product code for uCT 780 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.