K253077
- 510(k) number
- K253077
- Device name
- uOmnispace.MR
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-04-22
- Date received
- 2025-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253077.pdf
Official FDA record: K253077
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.