# K120187: Multi-Modality Image Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Igt, LLC Dba Eigen
- Decided: Apr 6, 2012 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: 7 generations back to K930090 (1993). 85 ancestors in all.
4 later devices descend from it; 2 cite it directly.
6 of 90 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 1.
- K081987: Unisyn Image Fusion, Version 1.0, Convergent Imaging Solutions (2008) Summary page 1.
- K093672: Aegis Navigation Anda Egis Pelvic Application, Sentinelle Medical, Inc. (2009) Summary page 1.
- K053610: Abaris, Traxtal Technologies, Inc. (2006) Summary page 1.

## Most influential descendants
- 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
- K140033: TARGET3D Fusion (2014), 0 descendants of its own

## Indications for use
Multi-Modalitj Image Fusion is a software application to be used by physicians in the clinic or hospital for 2-0 and 3-0 visualization, image registration, and fusion of MRI, CT and Ultrasound imaging modalities for mapping planning information across modalities. Additional software features include database management, data communication, surface rendering, segmentation, regions of interest (ROI) delineation, volumetric measurements, and data reporting.

Source page: https://510kreport.com/device/K120187
Methodology: https://510kreport.com/methodology