510(k) · Cleared
ClearedVitrea CT Lung Density Analysis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Images, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Oct 10, 2015 as substantially equivalent to K083227 (Vida Diagnostics, Inc., 2008) after an 89-day review. Its family tree reaches back 7 generations to 1995. 10 later devices descend from it.
- Decided
- Oct 10, 2015
- Review
- 89 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K954355 (1995). 11 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 6 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 5 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 4 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 3 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 2 generations backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- 1 generation backK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- This deviceK151919 Vitrea CT Lung Density Analysis SoftwareVital Images, Inc. · 2015
- Descendant · cites it directly · 6 of its ownK171199 AVIEWCoreline Soft Co., Ltd. · 2018
- Descendant · 2 generations on · 5 of its ownK200714 AVIEWCoreline Soft Co., Ltd. · 2020
- Descendant · 3 generations on · 4 of its ownK214036 AVIEWCoreline Soft Co., Ltd. · 2022
- Descendant · 4 generations on · 2 of its ownK233211 Aview CacCoreline Soft Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK232392 CT Lung Ventilation Analysis Software (CT:V)4Dmedical Limited · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K171199AVIEWCoreline Soft Co., Ltd. · 2018 · cites it directly6descendants
- K200714AVIEWCoreline Soft Co., Ltd. · 2020 · 2 generations on5descendants
- K214036AVIEWCoreline Soft Co., Ltd. · 2022 · 3 generations on4descendants
- K233211Aview CacCoreline Soft Co., Ltd. · 2024 · 4 generations on2descendants
- K232392CT Lung Ventilation Analysis Software (CT:V)4Dmedical Limited · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −6 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −5 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −4 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −3 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −2 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| −1 | K083227 | Vida Pulmonary Workstation 2 (PW2) | Vida Diagnostics, Inc. | 2008 | — |
| 0 (this device) | K151919 | Vitrea CT Lung Density Analysis Software | Vital Images, Inc. | 2015 | — |
| +1 | K171199 | AVIEW | Coreline Soft Co., Ltd. | 2018 | — |
| +2 | K200714 | AVIEW | Coreline Soft Co., Ltd. | 2020 | — |
| +3 | K214036 | AVIEW | Coreline Soft Co., Ltd. | 2022 | — |
| +4 | K233211 | Aview Cac | Coreline Soft Co., Ltd. | 2024 | — |
| +1 | K232392 | CT Lung Ventilation Analysis Software (CT:V) | 4Dmedical Limited | 2023 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K083227 | Vida Pulmonary Workstation 2 (PW2)Summary page 4…FDA 510(k) Number VIDA Diagnostics VIDA Pulmonary 100 Oakdale Campus, Suite 225 Tic K083227 Workstation 2 (PW2) Iowa City, IA 55242 064_ 510(k) Summary_S001… | 2008 |
| † | K043333 | VITREA2, Version 3.7 Medical Image Processing System | 2004 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K171199 (Coreline Soft Co., Ltd., 2018) has gone furthest, with 6 descendants of its own.
- 11 other devices also cite its predicate K083227.
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. 2015, 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 Vitrea Lung Density Analysis software provides CT values for the pulmonary tissue from CT thoracic datasets.
Three-dimensional (3D) segmentation of the left lung and right lung, volumetric analysis, density evaluations and reporting tools are integrated in a specific workflow to offer the physician a quantitative support for diagnosis and follow-up evaluation of lung tissue images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151919: Vitrea CT Lung Density Analysis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151919
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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