# K142196: Visage Ease Pro

- Pathway: 510(k) (Traditional)
- Applicant: Visage Imaging GmbH
- Decided: Apr 28, 2015 after 260 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: 10 generations back to K954874 (1996). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082269: Visage Pacs, Version 6.0/CS 3.1, Visage Imaging, Inc. (2008) Summary page 6.
- K112930: Mobile Mim, Mim Software, Inc. (2011) Summary page 6.

## Indications for use
Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images from the following modalities: X-ray, CT, MRI, PET, SPECT, Ultrasound and XA. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments. Visage Ease Pro must only be used by trained health care professionals. It may support physicians and/or the medical staff by providing mobile access to relevant medical images. Any diagnostic or therapeutic decision resides with the doctors and/or the medical staff in their respective area of responsibility. Visage Ease Pro is not intended to replace full radiologic reading workstations. It must not be used in the context of diagnostic or therapeutic decisions if a radiologic reading workstation with appropriate display hardware is available. The user must make sure that the reading environment complies with any applicable diagnostic requirements and the state-of-the-art. Visage Ease Pro must not be used for primary image diagnosis in mammography or digital breast tomosynthesis.

Source page: https://510kreport.com/device/K142196
Methodology: https://510kreport.com/methodology