# K041182: Syntegra

- Pathway: 510(k) (Traditional)
- Applicant: Adac Laboratories
- Decided: May 21, 2004 after 15 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930090 (1993). 13 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032036: Gemini 16, Philips Medical Systems (Cleveland), Inc. (2003) Summary page 1.

## Most influential descendants
- K061671: Syngo Trued, Model VC10A (2006), 11 descendants of its own
- K071241: LMS-Liver (2007), 9 descendants of its own
- K121213: Vitreaadvanced (2012), 8 descendants of its own
- K081987: Unisyn Image Fusion, Version 1.0 (2008), 7 descendants of its own
- K142521: Synapse 3D Liver and Kidney Analysis (2014), 5 descendants of its own

## Indications for use
SyntegraTM is a software application for multi-modality image registration and diagnostic fusion. Images are registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined functional and anatomical data providing different angular perspectives for interpretation by trained professionals

Source page: https://510kreport.com/device/K041182
Methodology: https://510kreport.com/methodology