# K261517: qCT Lung (v1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Qure.Ai Technologies Pvt., Ltd.
- Decided: Sep 14, 2026 after 130 days
- Product code: QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN180005 (2018). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242652: Lunit INSIGHT DBT v1.1, Lunit, Inc. (2024) Summary page 5.

## Indications for use
The qCT Lung is a diagnostic image analysis tool intended to be used as a concurrent reader for the analysis of CT scans from lung cancer screening population. qCT Lung assists radiologists and pulmonologists in the detection of pulmonary nodules of size 4-30 mm, provides characterization, and quantification of the region of interest (ROI). Characterization of nodules involves features of texture (solid, part-solid, and ground glass), spiculation status, and calcification status. Quantification includes information on the volume and diameter of the region of interest. qCT Lung provides adjunctive information and is not intended to be used as a replacement for a complete interpreting physician's review or clinical judgment. qCT Lung is also not intended to be used without the original CT series.

Source page: https://510kreport.com/device/K261517
Methodology: https://510kreport.com/methodology