# K250301: Merge Universal Viewer (MUV)

- Pathway: 510(k) (Traditional)
- Applicant: Merge Healthcare Incorporated
- Decided: Apr 14, 2025 after 73 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K904519 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203104: IBM iConnect Access, Merge Healthcare Incorporated (2021) Summary page 5.

## Indications for use
Merge Universal Viewer (MUV) is intended to provide internet access to multi-modality softcopy medical images, medical data, reports, and other patient-related information to conduct diagnostic review, processing, analyzing, reporting and sharing of DICOM-compliant medical images and relevant digital data. MUV provides functionality that allows for creating and outputting digital files suitable for the fabrication of physical replicas, such as 3D printing, using DICOM files as inputs. Physical/3D printed models generated from the digital output files are not for diagnostic use. MUV is intended to be used by trained healthcare professionals. MUV can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Use of MUV on mobile devices such as iPhones and iPads is not intended for diagnostic use.

Source page: https://510kreport.com/device/K250301
Methodology: https://510kreport.com/methodology