# K002239: Sigma 110/330 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Kontron Medical Systems Sas
- Decided: Aug 8, 2000 after 15 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
No predicates in its family tree.
6 later devices descend from it; 3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K061437: Sigma 5000 Series, Imagic (2006), 3 descendants of its own
- K053084: Sigma 5000 Series Imagic Ultrasound System (2005), 3 descendants of its own
- K050099: Sigma 5000 Series Imagic Ultrasound System (2005), 3 descendants of its own
- K081919: UF-870 AG Diagnostic Ultrasound System (2008), 2 descendants of its own
- K110920: UF-760AG (2011), 1 descendant of its own

Source page: https://510kreport.com/device/K002239
Methodology: https://510kreport.com/methodology