510(k) · Cleared
ClearedqCT LN Quant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qure.Ai Technologies · QIH Automated Radiological Image Processing Software
Cleared on Aug 16, 2024 as substantially equivalent to K202990 (Nines, Inc., 2021) and 1 other predicate after a 151-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Aug 16, 2024
- Review
- 151 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K913770 (1991). 36 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK151283 Lung Analysis SoftwareVital Images, Inc. · 2015
- 2 generations backK162484 Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V. · 2017
- 1 generation backK202990 NinesMeasureNines, Inc. · 2021
- This deviceK240740 qCT LN QuantQure.Ai Technologies · 2024
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 8 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 7 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 6 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 5 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 4 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 3 generations backK151283 Lung Analysis SoftwareVital Images, Inc. · 2015
- 2 generations backK162484 Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V. · 2017
- 1 generation backK202990 NinesMeasureNines, Inc. · 2021
- This deviceK240740 qCT LN QuantQure.Ai Technologies · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −8 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −7 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −6 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −5 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −4 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −3 | K151283 | Lung Analysis Software | Vital Images, Inc. | 2015 | — |
| −2 | K162484 | Lung Nodule Assessment and Comparison Option (LNA) | Philips Medical Systems Nederland B.V. | 2017 | — |
| −1 | K202990 | NinesMeasure | Nines, Inc. | 2021 | — |
| 0 (this device) | K240740 | qCT LN Quant | Qure.Ai Technologies | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K202990 | NinesMeasureSummary page 4…QIH 3 PREDICATE DEVICES Name of Device: Ninesmeasure Manufacturer: Nines, Inc. 510(k) Number: K202990 Regulatory Class: Class II Regulation Number: 21 CFR 892.2050 Product Code:… | 2021 |
| * | K162484 | Lung Nodule Assessment and Comparison Option (LNA)Summary page 4…Lung Nodule Assessment and Comparison Option (LNA) Manufacturer: Philips Medical Systems Nederland B.V. 510(k) Number: K162484 Regulatory Class: Class II Regulation Number: 21 CFR 892.2050; 21 CFR 892.1750 Product Code… | 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 33 years and passes through 7 companies; a new generation was cleared every 3.5 years on median.
- 8 of the 36 ancestors have a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
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 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240740 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240740: qCT LN Quant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240740
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026