510(k) · Cleared
Recalled · Class II · 2019Somatom Definition Edge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on May 23, 2012 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 123 devices in its family, counting itself, has a Class I recall. 122 later devices descend from it. It has been recalled 3 times.
- Decided
- May 23, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 3
- Predicates
- 0
122 later devices descend from it, 6 citing it directly. 1 of the 123 devices in this family, counting this one, has a Class I recall.
- This deviceK120579 Somatom Definition EdgeSiemens Medical Systems, Inc. · 2012
- Descendant · cites it directly · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · 2 generations on · 46 of its ownK150843 syngo®.via (version VB10A)Siemens AG · 2015
- Descendant · cites it directly · 35 of its ownK143401 SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- Descendant · cites it directly · 32 of its ownK143400 SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 28 of its ownK152036 SOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · Recalled
Showing 5 of 122 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…4 generations on · 2025
Most influential descendants
Showing 5 of 122 · See all- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · cites it directly63descendants
- K150843syngo®.via (version VB10A)Siemens AG · 2015 · 2 generations on46descendants
- K143401SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. · 2015 · cites it directly35descendants
- K143400SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · cites it directly32descendants
- K152036SOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · 2 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120579 | Somatom Definition Edge | Siemens Medical Systems, Inc. | 2012 | — |
| +1 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +2 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
| +1 | K143401 | SOMATOM Definition Edge | Siemens Medical Solutions USA, Inc. | 2015 | 3 |
| +1 | K143400 | SOMATOM Definition AS/AS+ | Siemens Medical Solutions USA, Inc. | 2015 | 5 |
| +2 | K152036 | SOMATOM Definition Edge, SOMATOM Definition AS/AS+ | Siemens Medical Solutions USA, Inc. | 2015 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 8 | 0 |
| 2018 | 11 | 0 |
| 2019 | 10 | 0 |
| 2020 | 13 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 14 | 0 |
| 2024 | 12 | 0 |
| 2025 | 16 | 1 |
| 2026 | 10 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (122)
See all 1226 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 3, 2019 | Class II | Z-2269-2019 | Software design | Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. |
| Mar 2, 2016 | Class II | Z-1521-2016 | Software design | Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental… |
| Nov 15, 2013 | Class II | Z-0907-2014 | Software design | During clinical operation, a malfunction may occur causing a system display freeze with SOMATOM Definition, Definition AS, and definition Edge while running software version syngo CT2012 B and syngo CT2013B. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K123920 (Siemens AG Medical Solutions, 2013) has gone furthest, with 63 descendants of its own.
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. 2012, 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 | — |
https://510kreport.com/device/K120579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120579: Somatom Definition Edge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120579
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026