# Breakaway Imaging, LLC

- Location (FDA's records): Littleton, MA
- FDA decisions: 2 (2005–2006): 2 510(k) clearances
- Product codes: OXO (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 5 (1 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Corp.: 1 (https://510kreport.com/company/siemens)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Firms that cite its devices most
- Mazor Surgical Technologies, Ltd.: 2 (https://510kreport.com/company/mazor-surgical-technologies)
- Medtronic Navigation, Inc. (Littleton): 2 (https://510kreport.com/company/medtronic-navigation-littleton)

## Its most-cited devices
- K050996: O-Arm Imaging System (2005), cited by 3
- K060344: O-Arm Imaging System (2006), cited by 2

## Recent decisions
- K060344: O-Arm Imaging System (Mar 29, 2006)
- K050996: O-Arm Imaging System (May 5, 2005)

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