Merge Universal Viewer (MUV)
by Merge Healthcare Incorporated United States EUDAMED510(k)
510(k) K250301 Product code LLZ
Overview
The Merge Universal Viewer (MUV) is a medical imaging workstation designed for the display and interpretation of radiologic images. As a diagnostic imaging device, it integrates multiple imaging modalities, including CT, MRI, X-ray, and ultrasound, to provide clinicians with a unified platform for reviewing and analyzing diagnostic studies.
The MUV is supplied as a reusable, non-sterile device intended for use in radiology departments, hospitals, and clinical imaging centers. It operates in non-MRI environments and is available in standard configurations tailored for clinical workflows. Authorized under FDA 510(k) clearance and MDD compliance, the device adheres to regulatory standards for diagnostic imaging systems, ensuring reliability and performance in clinical settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK250301 | Date14 Apr 2025 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Merge Healthcare Incorporated
Questions
What types of medical imaging studies can the Merge Universal Viewer (MUV) display and analyze?
The Merge Universal Viewer (MUV) is designed to integrate and display multiple imaging modalities, including CT scans, MRI images, X-rays, and ultrasound studies. This unified platform allows clinicians to review and analyze diagnostic studies from these different modalities in a single workflow, improving efficiency and diagnostic accuracy.
Is the Merge Universal Viewer (MUV) intended for use in MRI environments?
No, the MUV is explicitly designed for use in non-MRI environments only. This means it should not be placed inside or near an MRI scanner, as it is not MRI-compatible or shielded for such environments.
How is the Merge Universal Viewer (MUV) supplied, and is it single-use or reusable?
The MUV is supplied as a reusable, non-sterile device, intended for long-term use in radiology departments, hospitals, and clinical imaging centers. It is not intended for single-patient or single-use applications, but rather as a permanent workstation for diagnostic imaging workflows.
What regulatory pathways does the Merge Universal Viewer (MUV) follow, and how does this affect its use?
The MUV is authorized under FDA 510(k) clearance and complies with the Medical Device Directive (MDD). This means it has undergone regulatory review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets safety and performance standards for diagnostic imaging systems in clinical settings.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K250301
- EUDAMED