# K072653: 3VISEON/Surgery

- Pathway: 510(k) (Traditional)
- Applicant: 3Mensio Medical Imaging BV
- Decided: Jan 24, 2008 after 126 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: 4 generations back to K954678 (1996). 5 ancestors in all.
51 later devices descend from it; 2 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060505: Voxar 3D Enterprise, Model 6.1, Barcoview Mis Edinburgh (2006) Summary page 1.
- K043097: 3VISEON, 3Mensio Medical Imaging BV (2004) Summary page 1.

## Most influential descendants
- 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
- K171534: SurgicalPreview (2017), 10 descendants of its own

## Indications for use
3viseon/surgeryTM is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners). Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Image tools are available such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AveIP, MWP, MiniP, vascular measurements, annotations, reporting, distribution, etc. Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals. Digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must not be interpreted using this system.

Source page: https://510kreport.com/device/K072653
Methodology: https://510kreport.com/methodology