# K093146: IG4 Image Guided System, Model: Sys-0200

- Pathway: 510(k) (Traditional)
- Applicant: Veran Medical Technologies, Inc.
- Decided: Nov 30, 2009 after 56 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001284 (2000). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have 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.

## Most influential descendants
- K093995: IG 4 Image Guided System (2010), 2 descendants of its own
- K151414: IQQA Guide (2015), 1 descendant of its own
- K162314: IMACTIS CT-Navigation system (2018), 0 descendants of its own

## Recalls of this device
- Aug 10, 2023 · Class II · Z-2663-2023: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requir
- Aug 10, 2023 · Class II · Z-2661-2023: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requir
- Aug 10, 2023 · Class II · Z-2659-2023: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requir
- Aug 10, 2023 · Class II · Z-2662-2023: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requir
- Aug 10, 2023 · Class II · Z-2664-2023: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requir

## Indications for use
The ig4TM Image Guided System is a stereotactic accessory for Computed Tomography (CT) or 3D fluoroscopic x-ray 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 or 3D fluoroscopic x-ray-based model of the target organ(s). The ig4TM System compensates for the patient's respiratory phases. The ig4TM System is intended for use in clinical interventions and for anatomical structures where computed tomography or 3D fluoroscopic x-ray are currently used for visualizing such procedures.

Source page: https://510kreport.com/device/K093146
Methodology: https://510kreport.com/methodology