# K080013: Registration and Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare Corporation
- Decided: Jan 17, 2008 after 14 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: 1 generation back to K043441 (2005). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043441: Mirage, Release 5.5, Segami Corporation (2005) Summary page 1.

## Most influential descendants
- K111638: Impax Volume Viewing (2011), 4 descendants of its own
- K133135: Impax Volume Viewing 3.0 (2014), 3 descendants of its own
- K142316: IMPAX Agility (2015), 1 descendant of its own
- K252199: AGFA HealthCare Enterprise Imaging (2025), 0 descendants of its own
- K161061: IMPAX Volume Viewing 4.0 (2016), 0 descendants of its own

## Indications for use
Registration and Fusion (Basic and Extended) is indicated for the simultaneous visualization of multiple medical images of the same patient. The application can assist the user in visually matching and comparing anatomical studies taken at different times or acquired via different imaging modalities (Basic: CT-CT, CT-MR, MR-MR, Extended: CT-PET, MR-PET) as well as assist in making measurements. It is primarily used in the fields of diagnostic radiology, neurology and oncology.

Source page: https://510kreport.com/device/K080013
Methodology: https://510kreport.com/methodology