510(k) · Cleared
ClearedAutobone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Europe · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 20, 2003 as substantially equivalent to K972399 (Ge Medical Systems, Inc., 1997) and 1 other predicate after a 3-day review. Its family tree reaches back 2 generations to 1987. 58 later devices descend from it.
- Decided
- Jun 20, 2003
- Review
- 3 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K871859 (1987). 5 ancestors in all. 58 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK871859 CT9800 Quick 3D #B7919DAGeneral Electric Co. · 1987
- 1 generation backK972399 Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997 · Recalled
- This deviceK031871 AutoboneGe Medical Systems Europe · 2003
- Descendant · cites it directly · 55 of its ownK060779 Advance Vessel Analysis IIGE Healthcare · 2006
- Descendant · 2 generations on · 51 of its ownK061370 Cardiq FusionGE Healthcare · 2006
- Descendant · 3 generations on · 20 of its ownK103465 Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc. · 2011
- Descendant · 4 generations on · 19 of its ownK120636 Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012
- Descendant · 2 generations on · 19 of its ownK092747 Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K060779Advance Vessel Analysis IIGE Healthcare · 2006 · cites it directly55descendants
- K061370Cardiq FusionGE Healthcare · 2006 · 2 generations on51descendants
- K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc. · 2011 · 3 generations on20descendants
- K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc. · 2012 · 4 generations on19descendants
- K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc. · 2009 · 2 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871859 | CT9800 Quick 3D #B7919DA | General Electric Co. | 1987 | — |
| −1 | K972399 | Advantage Windows Volume Rendering Option | Ge Medical Systems, Inc. | 1997 | 1 |
| 0 (this device) | K031871 | Autobone | Ge Medical Systems Europe | 2003 | — |
| +1 | K060779 | Advance Vessel Analysis II | GE Healthcare | 2006 | — |
| +2 | K061370 | Cardiq Fusion | GE Healthcare | 2006 | — |
| +3 | K103465 | Synapse 3D Cardiac Tools | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
| +4 | K120636 | Synapse 3D Cardiac Tools | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| +2 | K092747 | Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment Tool | Philips Medical Systems (Cleveland), Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 4 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 10 | 0 |
| 2026 | 6 | 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? (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 |
|---|---|---|---|
| * | K972399 | Advantage Windows Volume Rendering OptionSummary page 2…lly equivalent to that of the following devices: Device Name FDA Clearance Number Volume Rendering K972399 Vitrea 2 KO025 19 Adverse Effects on Health: The potential hazards are identified in a r… | 1997 |
| * | K002519 | Vitrea 2, Version 2.1 | 2000 |
What descends from it? (58)
See all 583 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 3 companies; a new generation was cleared every 10.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K060779 (GE Healthcare, 2006) has gone furthest, with 55 descendants of its own.
- 1 other device also cites its predicate K972399.
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.
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 AutoBone option is a software package that is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data. It runs on Advantage Workstations, revision 4.1 or higher.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031871 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031871: Autobone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031871
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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