uMR Omega 88000196

The uMR Omega (model 88000196) is designed for high-resolution magnetic resonance imaging (MRI) to visualize soft tissues, organs, and pathological conditions. Since it operates using magnetic resonance principles, it provides detailed anatomical and functional imaging without ionizing radiation, making it useful for diagnosing a wide range of soft-tissue abnormalities, organ pathology, and other non-bony conditions.

The uMR Omega (model 88000196) is non-reusable and non-sterile, meaning it is not intended for reprocessing or implantation. However, the system itself can be reused within a facility’s protocols, as long as storage and handling comply with the manufacturer’s instructions to maintain performance and safety. The device’s non-sterile classification means it should not be used in sterile procedures unless prepared accordingly by the facility.

The uMR Omega (model 88000196) has been authorized through FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, ensuring it meets U.S. and EU regulatory standards. This means it can be legally marketed and used in the U.S. under FDA guidelines and in the EU under MDR requirements, though specific local regulations (e.g., installation, maintenance, or clinical protocols) may still apply.

The device’s UDI (Unique Device Identifier) 697157683011MR ensures full traceability throughout its lifecycle, allowing for accurate identification, recall management, and regulatory compliance. This UDI includes both a basic UDI (for the device itself) and a device identifier (DI) component, enabling healthcare providers and manufacturers to track specific units, verify authenticity, and maintain records as required by regulatory bodies.

While the manufacturer’s exact storage guidelines aren’t detailed here, the device’s non-sterile and non-reusable classification implies it must be stored in a clean, controlled environment to prevent contamination or damage. Since it is a Class IIa diagnostic imaging device, proper maintenance (e.g., calibration, shielding from magnetic interference) is critical to ensure imaging accuracy and patient safety. Always follow the manufacturer’s instructions to avoid compromising performance.