# K113680: Soma Access Systems Exacttrack Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: Soma Access Systems, LLC
- Decided: Dec 29, 2011 after 14 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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: 7 generations back to K911783 (1994). 66 ancestors in all.
No later device cites it as a predicate yet.
6 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092619: Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker, Civco (2009) Summary page 2.
- (no number) eTRAX Needle System: named in the summary without a submission number
- (no number) eTRAX Variable Angle Needle Guidance System: named in the summary without a submission number

## Recalls of this device
- Mar 24, 2014 · Class II · Z-0215-2015: There is a possibility the sterile packaging may fail before the expiration date specified on the package.

## Indications for use
The Soma Access Systems ExactTrackTM I Procedure Kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.

Source page: https://510kreport.com/device/K113680
Methodology: https://510kreport.com/methodology