# K151414: IQQA Guide

- Pathway: 510(k) (Traditional)
- Applicant: Edda Technology
- Decided: Nov 20, 2015 after 177 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: 5 generations back to K911783 (1994). 52 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093995: IG 4 Image Guided System, Veran Medical Technologies, Inc. (2010) Summary page 4.
- K053610: Abaris, Traxtal Technologies, Inc. (2006) Summary page 4.

## Most influential descendants
- K162314: IMACTIS CT-Navigation system (2018), 0 descendants of its own

## Indications for use
The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It displays simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows an imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments. The system supports the imaging-based model derived from physician’s confirmed segmentation results of patient’s image scans, including intra-operative CT, pre-procedural CT, and CT or MR previously acquired before surgical procedures. Additionally, overlaying ultrasound images (when available) may be displayed with the model of patient anatomy. The system supports a workflow based on automated image registrations of spatial mapping from one image space to another image space, or from image space to physical space. Physician may interactively adjust and confirm registration results, and evaluate 3D visualization and quantitative information in terms of distance, size, and spatial location associated with patient anatomy and instruments. The system is intended for intra-operative guidance for surgical procedures. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures.

Source page: https://510kreport.com/device/K151414
Methodology: https://510kreport.com/methodology