510(k) · Cleared
ClearedThoracic VCAR with GSI Pulmonary Perfusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems SCS · LLZ System, Image Processing, Radiological
Cleared on Mar 29, 2019 as substantially equivalent to K103480 (Ge Medical Systems, LLC, 2011) after a 130-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Mar 29, 2019
- Review
- 130 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K954355 (1995). 12 ancestors in all. No later device cites it as a predicate yet.
- 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 backK103480 Thoracic VcarGe Medical Systems, LLC · 2011
- This deviceK183210 Thoracic VCAR with GSI Pulmonary PerfusionGE Medical Systems SCS · 2019
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 | K103480 | Thoracic Vcar | Ge Medical Systems, LLC | 2011 | — |
| 0 (this device) | K183210 | Thoracic VCAR with GSI Pulmonary Perfusion | GE Medical Systems SCS | 2019 | — |
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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K103480 | Thoracic VcarSummary page 4…ndary Product Code: JAK Classification Panel: Radiology Regulatory Class: Class II Predicate Device: Thoracic VCAR 510(k) number K103480, cleared on March 7, 2011 Regulation Number/ 21CFR 892.2050, Picture archiving and communications Product Cod… | 2011 |
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 24 years and passes through 9 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 3 other devices also cite its predicate K103480.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
Thoracic VCAR is a CT, non-invasive image analysis software package, which may be used in conjunction with CT lung images to aid in the assessment of thoracic disease. The software provides automatic segmentation of the lungs and automatic segmentation and tracking of the airway tree. Thoracic VCAR also provides quantification of Hounsfield units and display by color of thresholds within a segmented region. Thoracic VCAR also supports Gemstone Spectral…
Read the full statement (155 words)
Thoracic VCAR is a CT, non-invasive image analysis software package, which may be used in conjunction with CT lung images to aid in the assessment of thoracic disease. The software provides automatic segmentation of the lungs and automatic segmentation and tracking of the airway tree. Thoracic VCAR also provides quantification of Hounsfield units and display by color of thresholds within a segmented region.
Thoracic VCAR also supports Gemstone Spectral Imaging (GSI) acquisitions for the evaluation of pulmonary perfusion. It provides additional information to aid in visualization of variations of perfusion within the lungs and to quantitatively assess lung volumes. It is intended to be used as an adjunct to current standard methods utilizing color coded displays of iodine attenuation differences in the lungs to aid in identifying segments of relative perfusion differences which may be useful in assessing thoracic disease. Thoracic diseases that may be associated with changes in perfusion include pulmonary embolism and COPD.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183210: Thoracic VCAR with GSI Pulmonary Perfusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183210
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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