# Kontron Medical Systems Sas

- Location (FDA's records): Redmond, WA
- FDA decisions: 4 (2000–2006): 4 510(k) clearances
- Product codes: IYN (4)
- Predicates its devices cite: 3 (3 its own); citations of its devices by later devices: 6 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Fukuda Denshi Co., Ltd.: 3 (https://510kreport.com/company/fukuda-denshi)

## Its most-cited devices
- K002239: Sigma 110/330 Diagnostic Ultrasound System (2000), cited by 3
- K061437: Sigma 5000 Series, Imagic (2006), cited by 1
- K053084: Sigma 5000 Series Imagic Ultrasound System (2005), cited by 1
- K050099: Sigma 5000 Series Imagic Ultrasound System (2005), cited by 1

## Recent decisions
- K061437: Sigma 5000 Series, Imagic (Jun 14, 2006)
- K053084: Sigma 5000 Series Imagic Ultrasound System (Nov 16, 2005)
- K050099: Sigma 5000 Series Imagic Ultrasound System (Jan 28, 2005)
- K002239: Sigma 110/330 Diagnostic Ultrasound System (Aug 8, 2000)

Source page: https://510kreport.com/company/kontron-medical-systems