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FDA 510(k)

Medical Image Post-processing Software (uOmnispace.CT)

K-Number: K242624 · 2025-05-14

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2025-05-14
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Medical Image Post-processing Software (uOmnispace.CT) is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2025-05-14 under approval number K242624. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Image Post-processing Software (uOmnispace.CT)?

Medical Image Post-processing Software (uOmnispace.CT) is a medical device that received FDA 510(k) clearance on 2025-05-14. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K242624.

When was Medical Image Post-processing Software (uOmnispace.CT) approved by the FDA?

Medical Image Post-processing Software (uOmnispace.CT) received FDA 510(k) clearance on 2025-05-14, under approval number K242624.

What company makes Medical Image Post-processing Software (uOmnispace.CT)?

Medical Image Post-processing Software (uOmnispace.CT) is manufactured by Shanghai United Imaging Healthcare Co., Ltd..

What is the FDA product code for Medical Image Post-processing Software (uOmnispace.CT)?

The FDA product code for Medical Image Post-processing Software (uOmnispace.CT) is QIH.

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Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42173550 Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care. BMJ health & care informatics (2026)

Other Devices by Shanghai United Imaging Healthcare Co., Ltd.

K182938Emission Computed Tomography System K173001uWS-CT K172999uWS-MR K182237uMI 550 PET/CT System K181371uMR 790 K181370uMR 780

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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.

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