# K050099: Sigma 5000 Series Imagic Ultrasound System

- Pathway: 510(k) (Abbreviated)
- Applicant: Kontron Medical Systems Sas
- Decided: Jan 28, 2005 after 10 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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 K002239 (2000). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002239: Sigma 110/330 Diagnostic Ultrasound System, Kontron Medical Systems Sas (2000) Summary page 1.

## Most influential descendants
- K081919: UF-870 AG Diagnostic Ultrasound System (2008), 2 descendants of its own
- K110920: UF-760AG (2011), 1 descendant of its own
- K131973: Unexef-38G Ultrasound System (2014), 0 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K050099
Methodology: https://510kreport.com/methodology