510(k) clearance
uPMR Zenith
- 510(k) number
- K261676
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
- Decision date
- Oct 28, 2026
- Date received
- May 21, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OUO
- Device type
- Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
- Device class
- Class II
- Regulation
- 21 CFR 892.1200
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Shanghai, CN