uOmnispace.MR
K-Number: K253077 · 2026-04-22
Decision Date2026-04-22
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uOmnispace.MR is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2026-04-22 under approval number K253077. 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 uOmnispace.MR?
uOmnispace.MR is a medical device that received FDA 510(k) clearance on 2026-04-22. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K253077.
When was uOmnispace.MR approved by the FDA?
uOmnispace.MR received FDA 510(k) clearance on 2026-04-22, under approval number K253077.
What company makes uOmnispace.MR?
uOmnispace.MR is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uOmnispace.MR?
The FDA product code for uOmnispace.MR is QIH.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
Related Devices (Code: QIH)
K191647QLAB Advanced Quantification SoftwarePhilips Health Care
K191171EchoGo CoreUltromics, Ltd.
K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.
K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.
K202546LVivo SeamlessDia Imaging Analysis, Ltd.
K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.
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.