510(k) · Cleared
ClearedBrainomix 360 e-Lung
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainomix Limited · JAK System, X-Ray, Tomography, Computed
Cleared on May 13, 2024 as substantially equivalent to K200990 (Vida Diagnostics, Inc., 2020) after a 158-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- May 13, 2024
- Review
- 158 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954355 (1995). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 7 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 6 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 5 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 4 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 3 generations backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- 2 generations backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- 1 generation backK200990 VIDAvisionVida Diagnostics, Inc. · 2020
- This deviceK233875 Brainomix 360 e-LungBrainomix Limited · 2024
- Descendant · cites it directly · 0 of its ownK242411 Brainomix 360 e-LungBrainomix Limited · 2025
Most influential descendants
Showing 1 of 1 · See all- K242411Brainomix 360 e-LungBrainomix Limited · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −7 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −6 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −5 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −4 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −3 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| −2 | K083227 | Vida Pulmonary Workstation 2 (PW2) | Vida Diagnostics, Inc. | 2008 | — |
| −1 | K200990 | VIDAvision | Vida Diagnostics, Inc. | 2020 | — |
| 0 (this device) | K233875 | Brainomix 360 e-Lung | Brainomix Limited | 2024 | — |
| +1 | K242411 | Brainomix 360 e-Lung | Brainomix Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K200990 | VIDAvisionSummary page 4…Diagnostics Inc. Regulation Number: 21 C.F.R. §892.1750 Regulatory Class: Class II Regulation Name: Computed tomography x-ray system Product Code: JAK Submission Number: K200990 2. Device Description Brainomix 360 e-Lung is a software package compliant with the DICOM standard and running on an off-the-s… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242411 | Brainomix 360 e-Lung | 2025 | 0 |
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 29 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K242411 (Brainomix Limited, 2025) has gone furthest, with 0 descendants of its own.
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. 2024, 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 e-Lung software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support in the examination of radiological findings. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses. The e-Lung software package is intended to be a workflow enhancement and visualization tool for the…
Read the full statement (109 words)
The e-Lung software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support in the examination of radiological findings. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses. The e-Lung software package is intended to be a workflow enhancement and visualization tool for the assessment of CT thoracic datasets. e-Lung can be used to support the physician when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. 3D segmentation, volumetric measurements, density evaluations, and reporting tools are combined with a dedicated workflow.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233875: Brainomix 360 e-Lung.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233875
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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