# Edlen Imaging, LLC

- Location (FDA's records): Scottsdale, AZ
- FDA decisions: 3 (2011–2016): 3 510(k) clearances
- Product codes: MUH (2), OAS (1)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 4 (1 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
- Schick Technologies, Inc.: 2 (https://510kreport.com/company/schick-technologies)
- Planmeca Oy: 1 (https://510kreport.com/company/planmeca)
- Genoray Co., Ltd.: 1 (https://510kreport.com/company/genoray)
- Suni Medical Imaging, Inc.: 1 (https://510kreport.com/company/suni-medical-imaging)

## Firms that cite its devices most
- Genoray Co., Ltd.: 1 (https://510kreport.com/company/genoray)
- Denterprise International, Inc.: 1 (https://510kreport.com/company/denterprise-international)
- Trident S.R.L: 1 (https://510kreport.com/company/trident)

## Its most-cited devices
- K103290: Edlen Imaging - Gemini Dusb (2011), cited by 2
- K150823: EDLENi Intra-Oral Sensor (2015), cited by 2

## Recent decisions
- K151137: X-View, Imagen (Jun 7, 2016)
- K150823: EDLENi Intra-Oral Sensor (Aug 26, 2015)
- K103290: Edlen Imaging - Gemini Dusb (Sep 19, 2011)

Source page: https://510kreport.com/company/edlen-imaging