uMR Omega with uWS-MR-MRS
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K220332 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 Omega with uWS-MR-MRS is a Magnetic Resonance Imaging (MRI) System designed for diagnostic imaging. It generates cross-sectional images—sagittal, transverse, coronal, and oblique—to visualize internal anatomical structures and functions of the head, body, and extremities.
This device is intended for use in clinical radiology settings and has received FDA 510(k) clearance and MDR authorization. It features an ultra-wide bore (75 cm) to accommodate varying patient sizes, ensuring compatibility with diverse clinical needs. The system is classified as a Class II medical device and is supplied as a reusable diagnostic tool.
Frequently asked questions
What types of anatomical images can the uMR Omega with uWS-MR-MRS produce, and how might this benefit clinical workflows?
The uMR Omega with uWS-MR-MRS generates cross-sectional images in four planes: sagittal, transverse, coronal, and oblique. This versatility allows radiologists to visualize internal structures of the head, body, and extremities from multiple angles, improving diagnostic accuracy and reducing the need for multiple scans. The ability to capture detailed images in these planes supports comprehensive evaluations for musculoskeletal, neurological, and soft-tissue assessments, streamlining workflows in clinical radiology settings.
Is the uMR Omega with uWS-MR-MRS designed to accommodate patients of varying sizes, and if so, how does this feature support clinical use?
Yes, the uMR Omega with uWS-MR-MRS features an ultra-wide bore of 75 cm, which is specifically designed to accommodate patients of diverse sizes, including those with limited mobility or larger body frames. This ensures compatibility with a broader range of clinical needs, reducing the risk of patient discomfort or exclusion due to size constraints, and enhances accessibility for imaging procedures.
How is the uMR Omega with uWS-MR-MRS supplied, and what does this mean for maintenance and operational costs in a clinical setting?
The uMR Omega with uWS-MR-MRS is supplied as a reusable diagnostic tool, meaning it is built for long-term use within a clinical environment. While this design supports cost efficiency by eliminating the need for single-use disposables, it also implies that facilities must invest in proper maintenance protocols, calibration, and cleaning procedures to ensure consistent performance, reliability, and compliance with regulatory standards over time.
What regulatory pathways has the uMR Omega with uWS-MR-MRS followed, and what does this indicate about its intended use and oversight?
The uMR Omega with uWS-MR-MRS has received FDA 510(k) clearance and MDR authorization, confirming its compliance with U.S. and European regulatory requirements for magnetic resonance imaging systems. These clearances indicate that the device has undergone rigorous evaluation by regulatory bodies to ensure safety, performance, and effectiveness for its intended use as a diagnostic imaging tool in clinical radiology settings. The classification as a Class II medical device further reflects its role in specialized medical diagnostics.
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 Omega with uWS-MR-MRS | Shanghai United Imaging Healthcare Co.,Ltd ..., uMR Omega: Ultra-wide Bore 3.0T MR | United-Imaging, uMR Omega with uWS-MR-MRS | Shanghai United Imaging Healthcare Co.,Ltd ..., uMR Omega with uWS-MR-MRS (K220332) — FDA 510(k) | Innolitics
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K220332 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
Sources (2)
- FDA 510(k) K220332 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026