# Ge Healthcare, Breas Medical AB

- Location (FDA's records): Molnlycke, SE
- FDA decisions: 1 (2013–2013): 1 510(k) clearance
- Product codes: NOU (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Phasein AB: 2 (https://510kreport.com/company/phasein)
- Versamed Medical Systems, Inc.: 1 (https://510kreport.com/company/versamed-medical-systems)
- Respironics, Inc.: 1 (https://510kreport.com/company/respironics)

## Firms that cite its devices most
- Breas Medical AB: 1 (https://510kreport.com/company/breas-medical)

## Its most-cited devices
- K123144: VIVO 50 (2013), cited by 1

## Recent decisions
- K123144: VIVO 50 (Jun 18, 2013)

Source page: https://510kreport.com/company/ge-healthcare-breas-medical