# Owandy

- Location (FDA's records): Ormond Beach, FL
- FDA decisions: 7 (2006–2014): 7 510(k) clearances
- Names in FDA's records: Owandy (6); Owandy Sas (1)
- Product codes: MUH (5), OAS (1), EHD (1)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 7 (3 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
- Villa Sistemi Medicali S.P.A.: 2 (https://510kreport.com/company/villa-sistemi-medicali)
- Afp Imaging Corp.: 1 (https://510kreport.com/company/afp-imaging)
- Trophy Radiologie: 1 (https://510kreport.com/company/trophy-radiologie)
- Visiodent SA: 1 (https://510kreport.com/company/visiodent)
- Air Techniques, Inc.: 1 (https://510kreport.com/company/air-techniques)
- Schick Technologies, Inc.: 1 (https://510kreport.com/company/schick-technologies)

## Firms that cite its devices most
- Villa Sistemi Medicali S.P.A.: 2 (https://510kreport.com/company/villa-sistemi-medicali)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Denterprise International, Inc.: 1 (https://510kreport.com/company/denterprise-international)

## Its most-cited devices
- K053172: Universal-X (Usa) or /Krystal-X (Europe) (2006), cited by 2
- K130443: I-Max Touch 3D (2013), cited by 1
- K070505: Krystal-X Wifi (2007), cited by 1
- K062403: Imax Ceph Digital X-Ray Sensor (2006), cited by 1
- K093105: Visteo (2010), cited by 1
- K133271: Opteo, Videograph HD (2014), cited by 1

## Recent decisions
- K133271: Opteo, Videograph HD (Apr 28, 2014)
- K130443: I-Max Touch 3D (Jun 14, 2013)
- K093105: Visteo (Oct 18, 2010)
- K083057: I-Max Touch (Jun 2, 2009)
- K070505: Krystal-X Wifi (Apr 5, 2007)
- K062403: Imax Ceph Digital X-Ray Sensor (Nov 14, 2006)
- K053172: Universal-X (Usa) or /Krystal-X (Europe) (Jun 9, 2006)

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