# Imaging Sciences International

- Location (FDA's records): Hatfield, PA
- FDA decisions: 3 (2014–2016): 3 510(k) clearances
- Names in FDA's records: Imaging Sciences International (2); Imaging Sciences International, LLC (1)
- Product codes: OAS (2), LLZ (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 5 (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
- Sirona Dental Systems GmbH: 2 (https://510kreport.com/company/sirona-dental-systems)
- Imaging Sciences Intl., Inc.: 1 (https://510kreport.com/company/imaging-sciences-intl)

## Firms that cite its devices most
- Yofo Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/yofo-medical-technology)
- Palodex Group OY: 1 (https://510kreport.com/company/palodex-group)
- Prexion Corporation: 1 (https://510kreport.com/company/prexion)
- Imaging Sciences International /Gendex/Dexis: 1 (https://510kreport.com/company/imaging-sciences-international-gendex-dexis)

## Its most-cited devices
- K140445: Dexis Software: Dexis Imaging Suite, Dexis Mac (2014), cited by 2
- K133620: Cone Beam 3D and 2D Panoramic Dental Imaging System (2014), cited by 2
- K162085: i-CAT FLX V series / KaVo 3D eXam+ V series (2016), cited by 1

## Recent decisions
- K162085: i-CAT FLX V series / KaVo 3D eXam+ V series (Nov 10, 2016)
- K133620: Cone Beam 3D and 2D Panoramic Dental Imaging System (May 14, 2014)
- K140445: Dexis Software: Dexis Imaging Suite, Dexis Mac (Apr 23, 2014)

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