510(k) · Cleared
ClearedSyngo, CT Bone Reading
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 12, 2013 as substantially equivalent to K112020 (Siemens Medi Cal Solutions, Inc., 2011) and 2 other predicates after a 111-day review. Its family tree reaches back 9 generations to 1996. 8 later devices descend from it.
- Decided
- Mar 12, 2013
- Review
- 111 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K954678 (1996). 86 ancestors in all, the oldest K837107 (1983). 8 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations between
- 3 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 2 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- This deviceK123584 Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK193267 Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK213944 HealthOSTNanoxai, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK183204 Bone VCAR (BVCAR)GE Medical Systems SCS · 2019
- Descendant · 3 generations on · 0 of its ownK233080 HealthFLDNano-X AI, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK223261 Open RibCanon Medical Informatics, Inc. · 2023
Show all 9 generations
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 7 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 6 generations backK022692 Voxelplus PacsMevisys Co., Ltd. · 2002
- 5 generations backK051528 Mevis Liveranalyser/Liverviewer SoftwareMevis Technology GmbH & Co. KG · 2005
- 4 generations backK061696 Iqqa-Liver SoftwareEdda Technology, Inc. · 2006
- 3 generations backK071310 Syngo CT Oncology Software PackageSiemens AG · 2007
- 2 generations backK083524 Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- This deviceK123584 Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc. · 2020 · cites it directly3descendants
- K213944HealthOSTNanoxai, Ltd. · 2022 · 2 generations on1descendant
- K183204Bone VCAR (BVCAR)GE Medical Systems SCS · 2019 · cites it directly1descendant
- K233080HealthFLDNano-X AI, Ltd. · 2024 · 3 generations on0descendants
- K223261Open RibCanon Medical Informatics, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −8 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −7 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −6 | K022692 | Voxelplus Pacs | Mevisys Co., Ltd. | 2002 | — |
| −5 | K051528 | Mevis Liveranalyser/Liverviewer Software | Mevis Technology GmbH & Co. KG | 2005 | — |
| −4 | K061696 | Iqqa-Liver Software | Edda Technology, Inc. | 2006 | — |
| −3 | K071310 | Syngo CT Oncology Software Package | Siemens AG | 2007 | — |
| −2 | K083524 | Syngo Dual Energy with Extended Funationally | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| 0 (this device) | K123584 | Syngo, CT Bone Reading | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +1 | K193267 | Al-Rad Companion (Musculoskeletal) | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +2 | K213944 | HealthOST | Nanoxai, Ltd. | 2022 | — |
| +1 | K183204 | Bone VCAR (BVCAR) | GE Medical Systems SCS | 2019 | — |
| +3 | K233080 | HealthFLD | Nano-X AI, Ltd. | 2024 | — |
| +1 | K223261 | Open Rib | Canon Medical Informatics, Inc. | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K112020 | Syngo.CT Vascular AnalysisSummary page 2…Predicate Device Name FACerne FDA Clearance Date Number Siemens syngo.CT Vascular Analysis K1 12020 08/18/2011 Siemens syngo Multimodality K072728 04/22/2008 Workplace… | 2011 |
| * | K072728 | Syngo Multimodality WorkplaceSummary page 2…Number Siemens syngo.CT Vascular Analysis K1 12020 08/18/2011 Siemens syngo Multimodality K072728 04/22/2008 Workplace Siemens SOMATOM Definition Edge K120579 05/23/2012… | 2008 |
| * | K120579 | Somatom Definition EdgeSummary page 2…08/18/2011 Siemens syngo Multimodality K072728 04/22/2008 Workplace Siemens SOMATOM Definition Edge K120579 05/23/2012 4. Device Description: syngo.CT Bone Reading is image analysis software for CT volume d… | 2012 |
What descends from it? (8)
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 17 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 19 of the 86 ancestors have a recall of any class.
- Of its descendants, K193267 (Siemens Medical Solutions USA, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K112020.
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. 2013, 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 syngo.CT Bone Reading is image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging systems. The software combines following digital image processing and visualization tools: multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT) geometric measurement tools (distance line, polyline, marker…
Read the full statement (142 words)
The syngo.CT Bone Reading is image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging systems. The software combines following digital image processing and visualization tools:
multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)
geometric measurement tools (distance line, polyline, marker, arrow, angle)
HU measurement tools (Pixel lens, ROI circle, ROl polygonal, ROl freehand, VOl sphere)
curved MPR visualization (unfolded ribs and spine views), cross-section MPRs
tools for creation and editing of anatomical centerline paths
tools for creation and editing of anatomical labels
The specific visualizations of spine and rib structures allow for easy manual identification and marking of pathologies such as bone lesions or fractures. Reporting and documentation of results is facilitated by using of appropriate reporting tool, statistics and creation of ranges and snapshots.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123584 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123584: Syngo, CT Bone Reading.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123584
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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