510(k) · Cleared
ClearedLungQ 4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thirona BV · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 2, 2025 as substantially equivalent to K232412 (Thirona BV, 2024) after a 203-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Oct 2, 2025
- Review
- 203 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K954355 (1995). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 5 generations between
- 3 generations backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- 2 generations backK173821 LungQ SoftwareThirona Corporation · 2018
- 1 generation backK232412 LungQ v3.0.0Thirona BV · 2024
- This deviceK250766 LungQ 4Thirona BV · 2025
Show all 9 generations
- Root · 9 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 8 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 7 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 6 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 5 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 4 generations backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- 3 generations backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- 2 generations backK173821 LungQ SoftwareThirona Corporation · 2018
- 1 generation backK232412 LungQ v3.0.0Thirona BV · 2024
- This deviceK250766 LungQ 4Thirona BV · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −8 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −7 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −6 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −5 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −4 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| −3 | K083227 | Vida Pulmonary Workstation 2 (PW2) | Vida Diagnostics, Inc. | 2008 | — |
| −2 | K173821 | LungQ Software | Thirona Corporation | 2018 | — |
| −1 | K232412 | LungQ v3.0.0 | Thirona BV | 2024 | — |
| 0 (this device) | K250766 | LungQ 4 | Thirona BV | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K232412 | LungQ v3.0.0Summary page 7…ct device) (Predicate Device) 510(k) Number K250766 K232412 Product Code JAK Same Regulation Number… | 2024 |
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 30 years and passes through 9 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 13 ancestors has a recall of any class.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The Thirona LungQ software provides reproducible CT values for pulmonary tissue and specified endobronchial implants which is essential for providing quantitative support for diagnosis, treatment planning and follow up examination. The LungQ software can be used to support physician in the diagnosis and documentation of pulmonary tissues images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, estimated chronic perfusion defect analysis, fissure evaluation and reporting tools are provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250766: LungQ 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250766
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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