uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis

Shanghai United Imaging Healthcare Co.,Ltd. · K243617 · 2025-05-16

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis is an AI-enabled medical device from Shanghai United Imaging Healthcare Co.,Ltd., listed by FDA (510(k), K243617) with a decision date of 2025-05-16. Review panel: Radiology.

FDA submission numberK243617
Pathway510(k)
CompanyShanghai United Imaging Healthcare Co.,Ltd.
Review panel (specialty)Radiology
FDA decision date2025-05-16
DecisionSubstantially Equivalent
Product codeJAK
ClassificationSystem, X-Ray, Tomography, Computed
Device class2
Regulation number892.1750
Review time (calendar days)175
Applicant countryCN

Official FDA database record · FDA AI-enabled device list

More devices from Shanghai United Imaging Healthcare Co.,Ltd. · All Radiology AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.