# K180522: IGTFusion

- Pathway: 510(k) (Traditional)
- Applicant: Igi Technologies
- Decided: Aug 16, 2018 after 170 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: 10 generations back to K954874 (1996). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081076: Velocityais, Velocity AI, Velocityvx, Velocityrt, V-Response, Velocity Medical Solutions, LLC (2008) Summary page 6.

## Indications for use
IGTFusion is a stand-alone software product that provides the physician 3 means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning, interventional radiology and other medical Specialties. IGTFusion is not intended for mammography diagnosis.

Source page: https://510kreport.com/device/K180522
Methodology: https://510kreport.com/methodology