Identifiers
- 510(k) Number
- K191157 FDA 510(k)
- FDA Product Code
- LNH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The uMR 780 and uMR 790 are 3.0 Tesla (3.0T) Magnetic Resonance Imaging (MRI) Systems, designed for high-field radiology applications. These devices utilize advanced magnetic resonance technology to generate detailed images of internal body structures, enabling diagnostic evaluation of soft tissues, organs, and vascular systems with high spatial resolution and contrast.
These MRI systems are intended for use in clinical radiology settings and are supplied as reusable, non-sterile equipment. The uMR 780 and uMR 790 are classified as Class II devices under FDA regulations and comply with the Medical Device Directive (MDD). They are authorized for MRI-safe environments, adhering to strict electromagnetic interference and safety standards. The systems are intended for installation in dedicated MRI rooms and require proper maintenance and calibration to ensure accurate imaging performance.
Frequently asked questions
Are the uMR 780 and uMR 790 MRI systems reusable or single-use, and what does that mean for maintenance and cleaning requirements?
The uMR 780 and uMR 790 are reusable, non-sterile MRI systems. As reusable equipment, they require regular maintenance, calibration, and cleaning according to manufacturer guidelines to ensure optimal performance and patient safety. Unlike single-use devices, these systems are designed for repeated use in clinical radiology settings, but proper care is essential to maintain imaging accuracy and comply with electromagnetic interference and safety standards.
What field strength do the uMR 780 and uMR 790 MRI systems operate at, and how does this affect imaging capabilities?
The uMR 780 and uMR 790 are 3.0 Tesla (3.0T) MRI systems, which provide high-field strength for superior imaging resolution and contrast. This enables detailed visualization of soft tissues, organs, and vascular structures, making them suitable for advanced diagnostic evaluations in radiology.
What type of regulatory approvals do the uMR 780 and uMR 790 MRI systems hold, and how does this impact their use?
The uMR 780 and uMR 790 are authorized under FDA 510(k) clearance and comply with the Medical Device Directive (MDD). This means they meet U.S. and EU regulatory standards for safety and performance, allowing their use in MRI-safe environments where electromagnetic interference and safety protocols are strictly followed. The systems are classified as Class II devices under FDA regulations.
Where are the uMR 780 and uMR 790 intended to be installed, and what environmental or infrastructure requirements do they have?
These MRI systems are intended for installation in dedicated MRI rooms, where proper shielding, ventilation, and electromagnetic interference controls are in place. They require regular maintenance and calibration to ensure accurate imaging performance, as specified by the manufacturer. The systems are designed for clinical radiology settings and must adhere to strict safety standards for high-field MRI environments.
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: uMR® 790: 3.0T MR | United-Imaging Healthcare, uMR® 780: ACS 3.0T MR | United-Imaging Healthcare, uMR® 780: ACS 3.0T MR | United-Imaging Healthcare
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K191157 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
Sources (2)
- FDA 510(k) K191157 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026