# K060344: O-Arm Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Breakaway Imaging, LLC
- Decided: Mar 29, 2006 after 47 days
- Product code: OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003266 (2000). 5 ancestors in all.
51 later devices descend from it; 2 cite it directly.
2 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050996: O-Arm Imaging System, Breakaway Imaging, LLC (2005) Summary page 1.

## Most influential descendants
- K081672: C-Insight (2008), 33 descendants of its own
- K102130: Tenzing System (2010), 31 descendants of its own
- K110911: Renaissance System (2011), 24 descendants of its own
- K113228: Renaissance System (2011), 23 descendants of its own
- K140167: Renaissance X System (2014), 21 descendants of its own

## Recalls of this device
- May 10, 2010 · Not classified · Z-1998-2010: The possibility that the real time image display can freeze up during use of a 2D continuous fluoroscopy.

## Indications for use
The O-arm™ Imaging System is designed for 2D fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-arm™ Imaging System is compatible with certain Image Guided Surgical Systems.

Source page: https://510kreport.com/device/K060344
Methodology: https://510kreport.com/methodology