uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
FDA 510(k) K243538 · Shanghai United Imaging Healthcare Co., Ltd.
510(k) numberK243538
Submission
- Device name
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
- Applicant
- Shanghai United Imaging Healthcare Co., Ltd.
Shanghai, CN - Received
- November 15, 2024
- Decision date
- December 12, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261305 | Micsi-PetKPS · Traditional | Microstructure Imaging, Inc. | 09/11/2026SE |
| K261427 | uMI Panvivo (uMI Panvivo M)KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 07/28/2026SE |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…KPS · Special | Siemens Medical Solutions USA, Inc. | 05/21/2026SE |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 04/03/2026SE |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 02/13/2026SE |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…KPS · Special | Spectrum Dynamics Medical, Ltd. | 01/13/2026SE |
| K253844 | AnyScan 3.0 NM Scanner FamilyKPS · Traditional | Mediso Medical Imaging Systems, Ltd. | 12/30/2025SE |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21KPS · Traditional | Canon Medical Systems Corporation | 12/01/2025SE |
| K251401 | PennPET Explorer Positron Emission TomographKPS · Traditional | Trustees of the University of Pennsylvania | 11/25/2025SE |
| K252477 | Hybrid Viewer (00859873006240)KPS · Special | Hermes Medical Solutions AB | 09/09/2025SE |
More from Hermes Medical Solutions AB
| 510(k) | Device | Decision |
|---|---|---|
| K253726 | uAngio AVIVA CXOWB · Traditional | 08/21/2026SE |
| K261427 | uMI Panvivo (uMI Panvivo M)KPS · Traditional | 07/28/2026SE |
| K260113 | uMR AstraLNH · Traditional | 05/22/2026SE |
| K253077 | uOmnispace.MRQIH · Traditional | 04/22/2026SE |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…KPS · Traditional | 04/03/2026SE |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…KPS · Traditional | 02/13/2026SE |
| K253173 | uCT 780 with uWS-CT-Dual Energy AnalysisJAK · Traditional | 01/20/2026SE |
| K252000 | uDR Arria & uDR ArisKPR · Traditional | 11/26/2025SE |
| K252371 | uMR 680LNH · Special | 09/25/2025SE |
| K250045 | uWS-Angio ProLLZ · Traditional | 09/24/2025SE |
Questions and answers
When was uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) cleared by the FDA?
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (K243538) received a 510(k) decision of Substantially Equivalent on December 12, 2024, 27 days after the submission was received.
What is the product code of K243538?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.