# K110812: CT-Guide Needle Guidance System

- Pathway: 510(k) (Traditional)
- Applicant: Activiews, Ltd.
- Decided: Jun 21, 2011 after 90 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: 2 generations back to K001284 (2000). 4 ancestors in all.
2 later devices descend from it; 2 cite 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.
- K011418: Ultraguide MR-Guide 3000, Ultraguide, Ltd. (2001) Summary page 1.

## Most influential descendants
- K113063: CT-Guide Needle Guidance System (2011), 1 descendant of its own
- K120300: CT-Guide Needle Guidance System (2012), 0 descendants of its own

## Indications for use
The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s). The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.

Source page: https://510kreport.com/device/K110812
Methodology: https://510kreport.com/methodology