# K070606: Visio+CD Viewer# KPSCDVE01

- Pathway: 510(k) (Traditional)
- Applicant: Keosys Sas
- Decided: Apr 24, 2007 after 50 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: 8 generations back to K954874 (1996). 33 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062163: Mimviewer, Mimvista Corp. (2006) Summary page 1.

## Most influential descendants
- K102000: Imagys (2010), 3 descendants of its own
- K160334: Advanced Medical Imaging Software Suite (KSWVWR) (2016), 2 descendants of its own
- K211655: aPROMISE (2021), 1 descendant of its own
- K220590: aPROMISE X (2022), 0 descendants of its own

## Indications for use
Visio+ CD Viewer is a software component that is used for viewing medical images stored on a CD-ROM. This software is not meant for primary image interpretation in mammography. Visio+ CD Viewer is located on the CD-ROM with the medical images. Visio+ CD Viewer provides tools for image review and manipulation which can only be used with the medical images present on the CD-ROM. Typical users of Visio+ CD Viewer are trained professionals, including physicians and radiologists.

Source page: https://510kreport.com/device/K070606
Methodology: https://510kreport.com/methodology