# K240740: qCT LN Quant

- Pathway: 510(k) (Traditional)
- Applicant: Qure.Ai Technologies
- Decided: Aug 16, 2024 after 151 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 10 generations back to K913770 (1991). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202990: NinesMeasure, Nines, Inc. (2021) Summary page 4.
- K162484: Lung Nodule Assessment and Comparison Option (LNA), Philips Medical Systems Nederland B.V. (2017) Summary page 4.

## Indications for use
qCT LN Quant is a software device used in the tracking, assessment, and quantitative characterization of detected pulmonary nodules. This automatically analyzes user-selected regions within lung CT to provide volumetric, diameter and computer analysis based on morphological characteristics in a single study, or over the time course of several thoracic studies. The system performs the measurements, allowing the preview of lung nodules in 2D and 3D reconstructed views and the respective measurements to be displayed. It is indicated for the evaluation of user detected solid pulmonary nodules.

Source page: https://510kreport.com/device/K240740
Methodology: https://510kreport.com/methodology