# K173444: Quantitative Total Extensible Imaging (QTxI)

- Pathway: 510(k) (Traditional)
- Applicant: Aiq Solutions, Inc.
- Decided: Jul 23, 2018 after 259 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K950279 (1995). 39 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122205: EXINI, Exini Diagnostics AB (2012) Summary page 4.

## Most influential descendants
- K233998: TRAQinform IQ (2024), 0 descendants of its own

## Indications for use
Quantitative Total Extensible Imaging (QTxI) is a software tool used to aid in evaluation and information management of digital medical images by trained medical professionals including, but not limited to, radiologists, oncologists, nuclear medicine physicians, medical imaging technologists, dosimetrists and physicists. The medical modalities of these medical images include DICOM CT and PET as supported by ACR/NEMA DICOM 3.0. QTxI assists in the following indications: • Receive, store, retrieve, display and process digital medical images. • Create, display and print reports from those images. • Provide medical professionals with the ability to display, register, and fuse medical images. • Identify Regions of Interest (ROIs) and perform ROI contouring allowing quantitative/statistical analysis of full or partial body scans. • Evaluate quantitative change in ROIs (total or partial body; individual ROI within individual) with 3D interactive rendering of images with highlighted ROIs.

Source page: https://510kreport.com/device/K173444
Methodology: https://510kreport.com/methodology