# K081672: C-Insight

- Pathway: 510(k) (Traditional)
- Applicant: Mazor Surgical Technologies, Ltd.
- Decided: Aug 15, 2008 after 63 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003266 (2000). 7 ancestors in all.
33 later devices descend from it; 2 cite it directly.
1 of 41 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003266: Siremobil Iso-C 3D, Siemens Medical Solutions USA, Inc. (2000) Summary page 2.
- K032280: Siremobil Iso-C 3D, Siemens AG (2003) Summary page 2.
- K040347: Siremobil Iso-C 3D, Siemens Medical Systems, Inc. (2004) Summary page 2.
- K050996: O-Arm Imaging System, Breakaway Imaging, LLC (2005) Summary page 2.
- K060344: O-Arm Imaging System, Breakaway Imaging, LLC (2006) Summary page 2.

## Most influential descendants
- 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
- K120812: Renaissance (2012), 21 descendants of its own

## Indications for use
The C-InSight software provides a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects particularly for orthopedic applications

Source page: https://510kreport.com/device/K081672
Methodology: https://510kreport.com/methodology