# K091934: IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to IG4 Endobronchial), Model Ins-0300

- Pathway: 510(k) (Traditional)
- Applicant: Veran Medical Technologies, Inc.
- Decided: Dec 2, 2009 after 155 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: 10 generations back to K926514 (1993). 20 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060903: IG4 Image Guided System, Veran Medical Technologies, Inc. (2006) Summary page 1.
- K081379: Modification to Inreach System, Superdimension, Ltd. (2008) Summary page 1.

## Most influential descendants
- K122106: Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath Always-on Tip Tracked Aspiration Needle (2012), 1 descendant of its own
- K170023: SPiN Thoracic Navigation System (2017), 0 descendants of its own

## Indications for use
The jg4TM Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The ig4 System is indicated for displaying: * An interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s). * Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires, in the pulmonary tract. The ig4TM System Compensates for the patient's respiratory phases. The ig4TM System is intended for use in clinical interventions and for anatomical stmuctures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.

Source page: https://510kreport.com/device/K091934
Methodology: https://510kreport.com/methodology