# K093787: Iguide Cappa

- Pathway: 510(k) (Traditional)
- Applicant: Cas Innovations GmbH & Co. KG
- Decided: Mar 11, 2010 after 92 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911783 (1994). 50 ancestors in all.
No later device cites it as a predicate yet.
6 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080624: Navstationirad Emt, Version 1.1, Cas Innovations AG (2008) Summary page 3.
- (no number) Introduction Needles and Stylets for vertebroplasty and kyphoplasty manufactured by Stryker Instruments: named in the summary without a submission number

## Indications for use
iGuide CAPPA is intended to be an intraoperative image-guided computer-assisted navigation system for minimally invasive interventions for interventional radiology. iGuide CAPPA can be used combination with imaging systems that create a 3D-based model of the anatomy, like Computer Tomography (CT) or C-arm systems. It displays the simulated image of a tracked device (needle) on a computer monitor screen that shows images of anatomic relevant regions of the patient. The system also allows the planning of trajectories and displays the planning information together with the simulated image of a tracked needle on a computer monitor screen. At the same time movements of the patient are taking into account. The device is intended to be used in clinical applications and for anatomic structures where computer tomography or c-arm is currently used for visualizing such devices.

Source page: https://510kreport.com/device/K093787
Methodology: https://510kreport.com/methodology