510(k) · Cleared
ClearedBone VCAR (BVCAR)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems SCS · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 8, 2019 as substantially equivalent to K123584 (Siemens Medical Solutions USA, Inc., 2013) after a 140-day review. Its family tree reaches back 10 generations to 1996. 1 later device descends from it.
- Decided
- Apr 8, 2019
- Review
- 140 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K954678 (1996). 87 ancestors in all, the oldest K837107 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations between
- 3 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- 1 generation backK123584 Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc. · 2013
- This deviceK183204 Bone VCAR (BVCAR)GE Medical Systems SCS · 2019
- Descendant · cites it directly · 0 of its ownK223424 Spine Auto ViewsGE Medical Systems SCS · 2023
Show all 10 generations
- Root · 10 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 9 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 8 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 7 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 6 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 5 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 4 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 3 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 2 generations backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- 1 generation backK123584 Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc. · 2013
- This deviceK183204 Bone VCAR (BVCAR)GE Medical Systems SCS · 2019
Most influential descendants
Showing 1 of 1 · See all- K223424Spine Auto ViewsGE Medical Systems SCS · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −9 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −8 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −7 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −6 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −5 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −4 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| −3 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −2 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| −1 | K123584 | Syngo, CT Bone Reading | Siemens Medical Solutions USA, Inc. | 2013 | — |
| 0 (this device) | K183204 | Bone VCAR (BVCAR) | GE Medical Systems SCS | 2019 | — |
| +1 | K223424 | Spine Auto Views | GE Medical Systems SCS | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 10 | 0 |
| 2002 | 3 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K123584 | Syngo, CT Bone ReadingSummary page 5…510(k) Premarket Notification Submission Predicate Device: Device Name: Syngo.CT Bone Reading 510(k) number: K123584 cleared on May 12, 2013 Regulation number/ 21 CFR 892.1750 Computed tomography x-ray system / Product Code:… | 2013 |
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 |
|---|---|---|---|
| K223424 | Spine Auto Views | 2023 | 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 23 years and passes through 9 companies; a new generation was cleared every 2.4 years on median.
- 19 of the 87 ancestors have a recall of any class.
- Of its descendants, K223424 (GE Medical Systems SCS, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K123584.
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. 2019, 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?
Bone VCAR is a post processing application for use in the analysis of CT images. The software is intended to support clinicians in the review of images that include the spine by providing tools to label the spine and optimize the display of anatomy within the CT image. Bone VCAR is designed to support the clinician in visualization of the spine, by providing initial identification of vertebrae to assist in report dictation. The software also assists the…
Read the full statement (132 words)
Bone VCAR is a post processing application for use in the analysis of CT images. The software is intended to support clinicians in the review of images that include the spine by providing tools to label the spine and optimize the display of anatomy within the CT image.
Bone VCAR is designed to support the clinician in visualization of the spine, by providing initial identification of vertebrae to assist in report dictation.
The software also assists the user by providing optimized display settings for easier identification of anatomy to facilitate fast image review and reporting of findings. Bone VCAR may be used for multiple care areas and is not specific to any disease state. It can be utilized during the review of various types of exams including trauma, oncology, and routine body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183204: Bone VCAR (BVCAR).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183204
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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