Medical Image Post-processing Software (uOmnispace.CT)

Shanghai United Imaging Healthcare Co., Ltd. · K242624 · 2025-05-14

Medical Image Post-processing Software (uOmnispace.CT) is an AI-enabled medical device from Shanghai United Imaging Healthcare Co., Ltd., listed by FDA (510(k), K242624) with a decision date of 2025-05-14. Review panel: Radiology.

FDA submission numberK242624
Pathway510(k)
CompanyShanghai United Imaging Healthcare Co., Ltd.
Review panel (specialty)Radiology
FDA decision date2025-05-14
DecisionSubstantially Equivalent
Product codeQIH
ClassificationAutomated Radiological Image Processing Software
Device class2
Regulation number892.2050
Review time (calendar days)253
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.