510(k) · Cleared
ClearedVida Pulmonary Workstation 2 (PW2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vida Diagnostics, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 18, 2008 as substantially equivalent to K071513 (Siemens Medical Solutions, 2007) after a 15-day review. Its family tree reaches back 6 generations to 1995. 49 later devices descend from it.
- Decided
- Nov 18, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954355 (1995). 10 ancestors in all. 49 later devices descend from it, 12 citing it directly.
- Root · 6 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
- 5 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
- 4 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
- 3 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- 2 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- 1 generation backK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- This deviceK083227 Vida Pulmonary Workstation 2 (PW2)Vida Diagnostics, Inc. · 2008
- Descendant · cites it directly · 10 of its ownK151919 Vitrea CT Lung Density Analysis SoftwareVital Images, Inc. · 2015
- Descendant · cites it directly · 10 of its ownK120648 Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · cites it directly · 9 of its ownK123540 Syngo CT Pulmo 3DSiemens Medical Systems, Inc. · 2013
- Descendant · cites it directly · 9 of its ownK130542 Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK183271 AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc. · 2019
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- K151919Vitrea CT Lung Density Analysis SoftwareVital Images, Inc. · 2015 · cites it directly10descendants
- K120648Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2012 · cites it directly10descendants
- K123540Syngo CT Pulmo 3DSiemens Medical Systems, Inc. · 2013 · cites it directly9descendants
- K130542Synapse 3D Lung and Abdomen AnalysisFujifilm Medical System U.S.A., Inc. · 2013 · cites it directly9descendants
- K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc. · 2019 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954355 | Advantage Windows 3D with Navigator Option | General Electric Co. | 1995 | — |
| −5 | K974715 | Advantage 3D XR | GE Medical Systems | 1998 | — |
| −4 | K984634 | 3D-Angio | Siemens Medical Corp. | 1999 | — |
| −3 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| −2 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| −1 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| 0 (this device) | K083227 | Vida Pulmonary Workstation 2 (PW2) | Vida Diagnostics, Inc. | 2008 | — |
| +1 | K151919 | Vitrea CT Lung Density Analysis Software | Vital Images, Inc. | 2015 | — |
| +1 | K120648 | Synapse 3D Lung and Abdomen Analysis | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +1 | K123540 | Syngo CT Pulmo 3D | Siemens Medical Systems, Inc. | 2013 | — |
| +1 | K130542 | Synapse 3D Lung and Abdomen Analysis | Fujifilm Medical System U.S.A., Inc. | 2013 | — |
| +2 | K183271 | AI-Rad Companion (Pulmonary) | Siemens Medical Solutions USA, Inc. | 2019 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 7 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K071513 | Inspace 4D Software Package with Extended FunctionalitySummary page 2…InSpace 4D - Software Package with Extended Functionality 510(k) Number: K071513 Date Cleared: June 26, 2007 Compliance with Special Special Controls: No special c… | 2007 |
What descends from it? (49)
See all 4912 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151919 | Vitrea CT Lung Density Analysis Software | 2015 | 10 |
| K120648 | Synapse 3D Lung and Abdomen Analysis | 2012 | 10 |
| K123540 | Syngo CT Pulmo 3D | 2013 | 9 |
| K130542 | Synapse 3D Lung and Abdomen Analysis | 2013 | 9 |
| K103480 | Thoracic Vcar | 2011 | 4 |
| K173821 | LungQ Software | 2018 | 3 |
| K200990 | VIDAvision | 2020 | 2 |
| K130552 | CT Pulmonary Analysis | 2014 | 2 |
| K093810 | BF-Navi | 2010 | 1 |
| K191550 | Broncholab | 2020 | 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 13 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K151919 (Vital Images, Inc., 2015) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K071513.
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. 2008, 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 VIDA Pulmonary Workstation 2 (PW2) software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. The PW2 can be used to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, low…
Read the full statement (112 words)
The VIDA Pulmonary Workstation 2 (PW2) software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. The PW2 can be used to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, low density cluster analysis, and reporting tools are combined with a dedicated workflow. The VIDA Pulmonary Workstation 2 (PW2) software package is also intended to be a real-time interactive evaluation in space and time for CT volume data sets that provides the reconstruction of two-dimensional images into a three-dimensional image format.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083227: Vida Pulmonary Workstation 2 (PW2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083227
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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