Identity
- Trade Name
- uPMR FDA UDI
- Generic Name
- PET/MRI system FDA UDI
- Device Name
- Positron Emission Tomography and Magnetic Resonance Imaging System FDA UDI
- Model / Reference
- uPMR 790 EUDAMEDFDA UDI88000741 EUDAMED
- Description
- Positron Emission Tomography and Magnetic Resonance Imaging System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971576830084 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06971576830084 EUDAMED
- FDA Product Code
- OUO FDA UDI
- EMDN Code
- Z11020701 MRI/PET SYSTEMS EUDAMED
- GMDN Term
- PET/MRI system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1200 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
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
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 uPMR 790 is a magnetic resonance imaging (MRI) system (Nomenclature Code: Z11020701) designed for high-resolution soft tissue visualization. Classified as a Class IIa medical device, it operates under the Medical Device Directive (MDD) and has received FDA 510(k) clearance, enabling cross-border use in regulated markets. Its primary function is to generate detailed cross-sectional images of internal body structures using magnetic resonance principles, facilitating diagnostic assessments in radiology settings.
The uPMR 790 is supplied as a non-sterile, non-reusable device and is intended for use in MRI-compatible environments with appropriate electromagnetic shielding. It is available in a single configuration (Model 88000741) and requires proper installation, calibration, and maintenance by trained personnel in accordance with manufacturer guidelines. The device adheres to UDI (Unique Device Identification) standards, with a BASIC UDI of B-06971576830084, ensuring traceability and regulatory compliance. No implantable, animal-derived, or medicinal product components are incorporated.
Frequently asked questions
What is the primary purpose of the uPMR 790 MRI system and where would it typically be used?
The uPMR 790 is designed for high-resolution soft tissue visualization, enabling detailed cross-sectional imaging of internal body structures using magnetic resonance principles. It is intended for diagnostic assessments in radiology settings, where clinicians rely on precise imaging to evaluate conditions affecting soft tissues, organs, and other anatomical features.
Is the uPMR 790 system reusable or single-use, and what does that mean for its maintenance?
The uPMR 790 is a non-reusable device, meaning it is not intended for repeated use after a single procedure or session. Since it is not sterile and not designed for reprocessing, it requires proper installation, calibration, and maintenance by trained personnel to ensure optimal performance and safety in MRI-compatible environments with electromagnetic shielding.
How do I identify the correct model of the uPMR 790, and is there a unique identifier for traceability?
The uPMR 790 is supplied as a single configuration with the model number 88000741. It also includes a BASIC UDI (B-06971576830084) for traceability and regulatory compliance, ensuring it can be tracked throughout its lifecycle in accordance with UDI standards.
Who is responsible for the distribution of the uPMR 790 in Europe, and how can I verify its regulatory compliance?
In Europe, the uPMR 790 is distributed by Shanghai International Holding Corp. GmbH (Europe). The device adheres to the Medical Device Directive (MDD) and has received FDA 510(k) clearance, ensuring cross-border regulatory compliance. The BASIC UDI and manufacturer details confirm its authorized status.
Does the uPMR 790 contain any animal-derived components or materials that could pose allergenic risks?
No, the uPMR 790 does not incorporate any animal-derived components, medicinal products, or implantable materials. This is explicitly confirmed in the device specifications, making it suitable for use in environments where such concerns may be relevant.
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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183014 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K222540 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K192672 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K234154 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06971576830084 | Class IIa | 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 b586a686-9c3a-47c9-b775-fc5a9d464864 61 fields · synced Oct 6, 2026
- FDA UDI 3a98b6e6-f15a-43f8-b20a-c125d669a690 35 fields · synced May 30, 2026
- FDA 510(k) K183014 1 fields · synced May 18, 2026