510(k) · Cleared
ClearedqCT Lung (v1.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qure.Ai Technologies Pvt., Ltd. · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Sep 14, 2026 as substantially equivalent to K242652 (Lunit, Inc., 2024) after a 130-day review. Its family tree reaches back 6 generations to 2018.
- Decided
- Sep 14, 2026
- Review
- 130 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN180005 (2018). No later device cites it as a predicate yet.
- Root · 6 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 5 generations backK181704 TransparaScreenpoint Medical B.V. · 2018
- 4 generations backK192287 TransparaScreenpoint Medical B.V. · 2019
- 3 generations backK211678 Lunit INSIGHT MMGLunit, Inc. · 2021
- 2 generations backK231470 Lunit INSIGHT DBTLunit, Inc. · 2023
- 1 generation backK242652 Lunit INSIGHT DBT v1.1Lunit, Inc. · 2024
- This deviceK261517 qCT Lung (v1.0)Qure.Ai Technologies Pvt., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −5 | K181704 | Transpara | Screenpoint Medical B.V. | 2018 | — |
| −4 | K192287 | Transpara | Screenpoint Medical B.V. | 2019 | — |
| −3 | K211678 | Lunit INSIGHT MMG | Lunit, Inc. | 2021 | — |
| −2 | K231470 | Lunit INSIGHT DBT | Lunit, Inc. | 2023 | — |
| −1 | K242652 | Lunit INSIGHT DBT v1.1 | Lunit, Inc. | 2024 | — |
| 0 (this device) | K261517 | qCT Lung (v1.0) | Qure.Ai Technologies Pvt., Ltd. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QDQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QDQ device
- #1 K241831 Transpara (2.1.0)score 15.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K242652 | Lunit INSIGHT DBT v1.1Summary page 5…3 PREDICATE DEVICE Name of Device: Lunit INSIGHT DBT v1.1 Manufacturer: Lunit Inc. 510(k) Number: K242652 Regulatory Class: Class II Regulation Number: 21 CFR 892.2090 Product Code… | 2024 |
| † | K161201 | ClearRead CT | 2016 |
| † | K162484 | Lung Nodule Assessment and Comparison Option (LNA) | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K242652.
How does its category compare?
All QDQ devicesQDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QDQ
10so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QDQ
216in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QDQ
No recall names QDQ since 2007.
Adverse event reports per year · QDQ
No MAUDE report names QDQ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 3 | 173 | 0 | 0 |
| 2021 | 5 | 169 | 0 | 0 |
| 2022 | 4 | 131 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 7 | 153 | 0 | 0 |
| 2025 | 5 | 216 | 0 | 0 |
| 2026 | 10 | 154 | 0 | — |
What is it indicated for?
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…
Read the full statement (122 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261517: qCT Lung (v1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261517
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026