510(k) · Cleared
ClearedThoracic Vcar
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · LLZ System, Image Processing, Radiological
Cleared on Mar 7, 2011 as substantially equivalent to K083227 (Vida Diagnostics, Inc., 2008) and 1 other predicate after a 101-day review. Its family tree reaches back 7 generations to 1995. 4 later devices descend from it.
- Decided
- Mar 7, 2011
- Review
- 101 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K954355 (1995). 11 ancestors in all. 4 later devices descend from it, 4 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 deviceK103480 Thoracic VcarGe Medical Systems, LLC · 2011
- Descendant · cites it directly · 0 of its ownK223071 Xenoview VDPPolarean, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK203783 ClariPulmoClaripi, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK183210 Thoracic VCAR with GSI Pulmonary PerfusionGE Medical Systems SCS · 2019
- Descendant · cites it directly · 0 of its ownK143294 Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation · 2015
Most influential descendants
Showing 4 of 4 · See all- K223071Xenoview VDPPolarean, Inc. · 2022 · cites it directly0descendants
- K203783ClariPulmoClaripi, Inc. · 2022 · cites it directly0descendants
- K183210Thoracic VCAR with GSI Pulmonary PerfusionGE Medical Systems SCS · 2019 · cites it directly0descendants
- K143294Adaptive Motion Correction (AMC), CSMC-001A and 4D AirwaysToshibamedical Systems Corporation · 2015 · cites it directly0descendants
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) | K103480 | Thoracic Vcar | Ge Medical Systems, LLC | 2011 | — |
| +1 | K223071 | Xenoview VDP | Polarean, Inc. | 2022 | — |
| +1 | K203783 | ClariPulmo | Claripi, Inc. | 2022 | — |
| +1 | K183210 | Thoracic VCAR with GSI Pulmonary Perfusion | GE Medical Systems SCS | 2019 | — |
| +1 | K143294 | Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways | Toshibamedical Systems Corporation | 2015 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 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? (2)
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 1…21CFR 892.2050 Picture archiving and communications system Product Code: 9OLLZ Predicate Device(s): K(083227: Vida Pulmonary Workstation 2 K(071513: Syngo InSpace 4D) Device Descriptio… | 2008 |
| * | K071513 | Inspace 4D Software Package with Extended FunctionalitySummary page 1…Product Code: 9OLLZ Predicate Device(s): K(083227: Vida Pulmonary Workstation 2 K(071513: Syngo InSpace 4D) Device Description: Thoracic VCAR is a CT post-processing software for the GE… | 2007 |
What descends from it? (4)
4 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 16 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, K223071 (Polarean, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 11 other devices also cite its predicate K083227.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 diagnosis and management. The software will provide automatic segmentation of the lungs and automatic segmentation and tracking of the airway tree.
The software will provide quantification of Hounsfield units and display by color the thresholds within a segmented region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103480 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103480: Thoracic Vcar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103480
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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