# K122106: Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath Always-on Tip Tracked Aspiration Needle

- Pathway: 510(k) (Traditional)
- Applicant: Veran Medical Technologies, Inc.
- Decided: Dec 21, 2012 after 157 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K926514 (1993). 21 ancestors in all.
1 later device descends 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)
- K091934: IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to IG4 Endobronchial), Model Ins-0300, Veran Medical Technologies, Inc. (2009) Summary page 1.

## Most influential descendants
- K170023: SPiN Thoracic Navigation System (2017), 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
- May 15, 2023 · Class II · Z-2263-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2269-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2267-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2268-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2266-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2264-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2265-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r
- May 15, 2023 · Class II · Z-2262-2023: Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could r

## Indications for use
The ig4 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 abiopsy 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 ig4 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 and/or endoscopic bronchoscopy are currently used for visualizing such procedures.

Source page: https://510kreport.com/device/K122106
Methodology: https://510kreport.com/methodology