K243547
- 510(k) number
- K243547
- Device name
- uMR Ultra
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd. CN
- Product code
- LNH — System, Nuclear Magnetic Resonance Imaging
- Decision date
- 2025-07-17
- Date received
- 2024-11-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K243547.pdf
Official FDA record: K243547
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.