# Paieon, Inc.

- Location (FDA's records): Rosh Haayin, IL
- FDA decisions: 8 (2004–2012): 8 510(k) clearances
- Product codes: IZI (7), OWB (1)
- Predicates its devices cite: 22 (7 its own); citations of its devices by later devices: 14 (7 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
- Medis Medical Imaging Systems BV: 3 (https://510kreport.com/company/medis-medical-imaging-systems)
- Pie Medical Imaging BV: 3 (https://510kreport.com/company/pie-medical-imaging)
- Philips Medical Systems North America, Inc.: 2 (https://510kreport.com/company/philips-medical-systems-north-america)
- Vital Images, Inc.: 2 (https://510kreport.com/company/vital-images)
- Tomtec Imaging Systems GmbH: 1 (https://510kreport.com/company/tomtec-imaging-systems)
- Siemens Medical Solutions USA, Inc., Ultrasound DI: 1 (https://510kreport.com/company/siemens-medical-solutions-usa-ultrasound-di)
- Superdimension, Ltd.: 1 (https://510kreport.com/company/superdimension)
- Volcano Corporation: 1 (https://510kreport.com/company/volcano)

## Firms that cite its devices most
- Pie Medical Imaging BV: 3 (https://510kreport.com/company/pie-medical-imaging)
- Sync-Rx, Ltd.: 1 (https://510kreport.com/company/sync-rx)
- Volcano Corporation: 1 (https://510kreport.com/company/volcano)
- Mediguide, Ltd.: 1 (https://510kreport.com/company/mediguide)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)

## Its most-cited devices
- K110256: The IC-Pro System (2011), cited by 4
- K083745: The IC-Pro System, Model Version 3.2 (2009), cited by 4
- K082907: IC-Pro System, Version 3.1.0.4 (2008), cited by 2
- K030139: The Cardiop-B System (2004), cited by 2
- K072591: Cardiop-B System, Version 2.1 (2007), cited by 1
- K073328: Cardiop-B System, Version 2.1 with Lva (2008), cited by 1

## Recent decisions
- K120282: Cardnav (Dec 10, 2012)
- K113594: C-THV System (Mar 2, 2012)
- K110256: The IC-Pro System (May 27, 2011)
- K083745: The IC-Pro System, Model Version 3.2 (Feb 17, 2009)
- K082907: IC-Pro System, Version 3.1.0.4 (Nov 18, 2008)
- K073328: Cardiop-B System, Version 2.1 with Lva (Sep 9, 2008)
- K072591: Cardiop-B System, Version 2.1 (Oct 10, 2007)
- K030139: The Cardiop-B System (Apr 2, 2004)

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