# K043097: 3VISEON

- Pathway: 510(k) (Traditional)
- Applicant: 3Mensio Medical Imaging BV
- Decided: Nov 19, 2004 after 10 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: 3 generations back to K954678 (1996). 3 ancestors in all.
52 later devices descend from it; 1 cites it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999) Summary page 1.

## Most influential descendants
- K072653: 3VISEON/Surgery (2008), 51 descendants of its own
- K120367: 3MENSIO Workstation (2012), 49 descendants of its own
- K153736: 3mensio Workstation (2016), 19 descendants of its own
- K141475: Endosize (2014), 16 descendants of its own
- K160376: EndoSize (2016), 13 descendants of its own

## Indications for use
3viseonTM is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. 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 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K043097
Methodology: https://510kreport.com/methodology