# K060903: IG4 Image Guided System

- Pathway: 510(k) (Traditional)
- Applicant: Veran Medical Technologies, Inc.
- Decided: May 11, 2006 after 38 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: 1 generation back to K001284 (2000). 2 ancestors in all.
47 later devices descend from it; 7 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002258: Ultraguide CT-Guide 1010, Ultraguide, Ltd. (2000) Summary page 1.
- K001284: Stealthstation System Goldeneye Micro-Magnetic Tracking System, Medtronic Surgical Navigation Technologies (2000)
- (no number) conventional soft tissue navigation with CT images: named in the summary without a submission number

## Most influential descendants
- K132108: MAXIO (2014), 27 descendants of its own
- K150313: Ablation Confirmation (2015), 16 descendants of its own
- K202297: Aline Ablation Intelligence (2020), 11 descendants of its own
- K083728: Invision System (2009), 8 descendants of its own
- K121479: AIM (2012), 5 descendants of its own

## Indications for use
The ig4TM Image Guided System is a stereotactic accessory for Computed Tomography (CT) Systems. The ig4 System displays an interventional instrument, such as a biopsy needle, an aspiration needle, or an ablation needle, on a computer monitor that also displays a CT-based model of the target organ(s). The ig4 System compensates for the patient's respiratory phases. The ig4 System is intended to be used in clinical interventions and for anatomical structures where computed tomography is currently used for visualizing such procedures.

Source page: https://510kreport.com/device/K060903
Methodology: https://510kreport.com/methodology