uMI Panorama 28 Positron Emission Tomography and Computed Tomography System
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- uMI FDA UDI
- Generic Name
- PET/CT system FDA UDI
- Device Name
- Positron Emission Tomography and Computed Tomography System EUDAMEDFDA UDI
- Model / Reference
- uMI Panorama 28 EUDAMEDFDA UDI88000922 EUDAMED
- Description
- Positron Emission Tomography and Computed Tomography System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971576832163 EUDAMEDFDA UDI
- Basic UDI-DI
- 697157683216ND EUDAMED
- FDA Product Code
- KPS FDA UDIJAK FDA UDI
- EMDN Code
- Z11020301 CT/PET SYSTEMS EUDAMED
- GMDN Term
- PET/CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 FDA UDI892.1750 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
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
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The uMI Panorama 28 is a hybrid imaging system combining Positron Emission Tomography (PET) and Computed Tomography (CT). It is classified under nomenclature code Z11020301 as a Class IIb diagnostic imaging device, enabling simultaneous metabolic and anatomical imaging for enhanced diagnostic accuracy in oncology, neurology, and cardiology.
This system is non-sterile, non-reusable, and non-implantable, supplied as a single-use or multi-use device depending on configuration. It operates under FDA 510K and MDR regulatory frameworks, with a Basic UDI of 697157683216ND. The device is designed for use in clinical settings, including MRI-safe environments where applicable, and requires proper storage to maintain performance integrity.
Frequently asked questions
What clinical specialties would benefit most from using this hybrid imaging system, and why?
This system is particularly valuable in oncology, neurology, and cardiology due to its ability to combine metabolic (PET) and anatomical (CT) imaging. Oncology benefits from improved tumor detection and characterization, neurology gains better visualization of brain function and structure, and cardiology achieves clearer assessment of blood flow and tissue viability. The simultaneous imaging reduces patient exposure time and enhances diagnostic accuracy across these specialties.
How is the uMI Panorama 28 configured for single-use versus multi-use applications, and what does that mean for clinical workflow?
The uMI Panorama 28 can be supplied as either single-use or multi-use depending on the specific configuration chosen. Single-use components ensure no risk of cross-contamination between patients, simplifying workflow by eliminating reprocessing steps. Multi-use configurations may reduce waste but require strict adherence to reprocessing protocols to maintain safety and performance, as outlined in the manufacturer’s instructions.
What storage requirements should be followed to ensure the device maintains its performance integrity?
The device must be stored according to manufacturer guidelines to preserve its performance, though specific details like temperature or environmental conditions aren’t provided in the data. Generally, hybrid imaging systems like this require protection from physical damage, extreme temperatures, and humidity. Ensure the device is kept in its original packaging until use, and follow any additional storage instructions provided by Shanghai United Imaging Healthcare Co., Ltd.
Who is the authorized representative for this device in Europe, and how does that affect procurement?
The authorized representative for this device in Europe is Shanghai International Holding Corp. GmbH (Europe), registered under SRN DE-AR-000000001. This means procurement in Europe must go through this entity, as they act as the legal intermediary between the manufacturer and regulatory bodies like the MDR. Always verify their contact details and compliance documentation before ordering.
Is this device compatible with MRI environments, and what implications does that have for clinical settings?
The device is designed for use in MRI-safe environments where applicable, meaning it can be operated in facilities with MRI scanners without causing interference. This compatibility expands its utility in multi-modal imaging centers, allowing seamless integration with other diagnostic tools. Clinicians should confirm specific MRI safety guidelines with the manufacturer to ensure proper co-location and operational protocols.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K232712 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K223325 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K241585 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K231572 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697157683216ND | 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 (3)
- EUDAMED fb8af615-c72b-4326-a2b5-b71cdb555c45 61 fields · synced Oct 6, 2026
- FDA UDI 782956e5-2be0-4904-8f6b-a96b15189dd0 35 fields · synced May 30, 2026
- FDA 510(k) K232712 1 fields · synced May 18, 2026