# K081987: Unisyn Image Fusion, Version 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Convergent Imaging Solutions
- Decided: Sep 26, 2008 after 74 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: 6 generations back to K930090 (1993). 15 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041182: Syntegra, Adac Laboratories (2004) Summary page 2.
- K001276: Medical Image Merge (Mim), Syntermed, Inc. (2000) Summary page 2.

## Most influential descendants
- K120187: Multi-Modality Image Fusion (2012), 4 descendants of its own
- K161109: iSR'obot MRI-US Fusion (2016), 2 descendants of its own
- K213411: iSR’obot Mona Lisa 2.0 (2021), 1 descendant of its own
- K232320: iSR`obot Mona Lisa 2.0 (2023), 0 descendants of its own
- K231047: UniSyn Molecular Imaging (6-3-1) (2023), 0 descendants of its own

## Indications for use
UniSyn is a software application for image registration and fusion display of scanned image data from CT, PET, SPECT and MR scanners. It is to be used by qualified radiology and nuclear medicine professionals. UniSyn creates multi-planar reformat and maximum intensity projection displays of the data and provides measurements such as area, volume and Standard Uptake Values for user defined regions on the image.

Source page: https://510kreport.com/device/K081987
Methodology: https://510kreport.com/methodology