uOmnispace.MR— 510(k) K253077
Substantially EquivalentShanghai United Imaging Healthcare Co., Ltd.
FDA 510(k) clearance K253077 for uOmnispace.MR, Substantially Equivalent on 2026-04-22. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.
Summary
Shanghai United Imaging Healthcare's uOmnispace.MR is filed under product code QIH (Automated Radiological Image Processing Software). The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Shanghai United Imaging Healthcare filed from Shanghai, China. The record shows 211 calendar days from receipt to decision (September 23, 2025 to April 22, 2026).
Clearance details
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code QIH
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