# K133901: Pari-Path Surgical Navigation System

- Pathway: 510(k) (Traditional)
- Applicant: Paritic, Inc.
- Decided: Jun 27, 2014 after 189 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: 8 generations back to K911783 (1994). 67 ancestors in all.
No later device cites it as a predicate yet.
6 of 68 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.
- K111818: Sonixgps Needle Sensor, Ultrasonix Medical Corporation (2012) Summary page 7.
- K092619: Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker, Civco (2009) Summary page 3.

## Cited in the summary but kept off the family tree
- K093046: Elibra Uni Soft-Tissue Force Sensor, Model 61-XXXX (5 Models, Different Sizes, Synvasive Technology, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The pani-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound imaging systems. It displays the simulated image of an interventions[ instrument ( a tracked insertion tool), such as a biopsy needle,an ablation needle ,or probe,on a computer monitor screen that shows an image model of the target organs and the current and the projected future path of the interventional instrument. Ultrasound imaging is incorporated with the pani-path surgical navigation system for the situation in which the target organs may move because of patients's respiratory. It is intended for treatment planning and intra-operative guidance for surgical procedures. It is intended for use in clinical interventionals and for anatomical structures where imaging is currently used for visualizing such procedures.

Source page: https://510kreport.com/device/K133901
Methodology: https://510kreport.com/methodology