# Stabilix, LLC

- Location (FDA's records): Dallas, TX
- FDA decisions: 2 (2026–2026): 2 510(k) clearances
- Product codes: IYE (2)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Elekta Instrument AB: 2 (https://510kreport.com/company/elekta-instrument)

## Recent decisions
- K261865: AerFrame™ Alignment Laser Box (LBV2) (Sep 16, 2026)
- K260792: AerFrame Patient Immobilization System (AFPIS) (May 8, 2026)

Source page: https://510kreport.com/company/stabilix