uMI Panvivo LS Positron Emission Tomography and Computed Tomography System
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Identity
- Device Name
- Positron Emission Tomography and Computed Tomography System EUDAMED
- Model / Reference
- uMI Panvivo LS EUDAMED88002709 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971576832330 EUDAMED
- Basic UDI-DI
- 697157683233ND EUDAMED
- EMDN Code
- Z11020301 CT/PET SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The uMI Panvivo LS is a Positron Emission Tomography and Computed Tomography System designed for advanced medical imaging applications. This diagnostic imaging device integrates PET and CT technologies to provide detailed anatomical and functional data for clinical evaluation.
This system is manufactured by Shanghai United Imaging Healthcare Co., Ltd. and is authorized under FDA 510K and MDR regulations. It is a non-sterile, non-implantable device that is not intended for reuse.
Frequently asked questions
What type of device is the uMI Panvivo LS?
The uMI Panvivo LS is a Positron Emission Tomography and Computed Tomography System, which is a diagnostic imaging device used to capture both functional and anatomical images.
Is the uMI Panvivo LS a sterile device?
No, the uMI Panvivo LS is not a sterile device, as it is a large-scale diagnostic imaging system rather than a surgical or invasive instrument.
What regulatory authorizations does this system hold?
The uMI Panvivo LS is authorized under both FDA 510K and MDR regulatory frameworks, ensuring it meets the necessary standards for its class.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: A PET/CT scan – what can it reveal, what are the indications and ..., uMI Vista: Digital PET/CT | United-Imaging Healthcare, uMI® 550: Digital PET/CT | United-Imaging Healthcare, Molecular Imaging (PET/CT & PET/MR) - United-Imaging, Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang ...
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253564 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K243538 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K251839 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K260524 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K193241 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K241596 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K182938 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697157683233ND | Class IIb | Active |
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Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000008501
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 45d3b198-fc0d-4a68-a478-235de66957f0 61 fields · synced Oct 7, 2026
- FDA 510(k) K253564 1 fields · synced Jun 9, 2026