# K080624: Navstationirad Emt, Version 1.1

- Pathway: 510(k) (Traditional)
- Applicant: Cas Innovations AG
- Decided: Apr 11, 2008 after 37 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: 5 generations back to K911783 (1994). 49 ancestors in all.
63 later devices descend from it; 2 cite it directly.
6 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053610: Abaris, Traxtal Technologies, Inc. (2006) Summary page 3.
- K002258: Ultraguide CT-Guide 1010, Ultraguide, Ltd. (2000) Summary page 3.
- K974432: Ultraguide 1000, Ultraguide, Ltd. (1998) Summary page 3.
- K990214: Fluoronav Module for the Stealthstation System, Surgical Navigation Technologies, Inc. (1999) Summary page 3.

## Most influential descendants
- K092619: Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker (2009), 61 descendants of its own
- K141459: Aplio 500/400/300 Diagnostic Ultrasound System, V5.0 (2014), 39 descendants of its own
- K151451: Aplio 500/400/300 Diagnostic Ultrasound System V6.0 (2015), 34 descendants of its own
- K161843: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 (2016), 23 descendants of its own
- K163702: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 (2017), 22 descendants of its own

## Indications for use
NavStationlrad EMT is intended to be an intraoperative image guided computer assisted navigation system for minimally invasive interventions for interventional radiology. NavStationlrad EMT can be used in 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 for use 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/K080624
Methodology: https://510kreport.com/methodology