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 Solutions USA, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 6, 2015 as substantially equivalent to K120579 (Siemens Medical Systems, Inc., 2012) and 1 other predicate after a 129-day review. Its family tree reaches back 6 generations to 1998. 35 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 6, 2015
- Review
- 129 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 6 generations to K982349 (1998). 8 ancestors in all. 35 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK982349 Somatom Plus 4WITH Volume Zoom CT ScannersSiemens Medical Solutions USA, Inc. · 1998
- 5 generations backK013522 Somatom P30 CT SystemsSiemens Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK040665 Somatom Sensation 64 and Sensation CardiacSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 3 generations backK081022 Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK103127 Somatom Definition asSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 1 generation backK130901 Somatom Definition as OpenSiemens Medical Systems, Inc. · 2014
- This deviceK143401 SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. · 2015
- Descendant · cites it directly · 28 of its ownK152036 SOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- Descendant · cites it directly · 20 of its ownK173630 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM…Siemens Medical Solutions USA, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 20 of its ownK173607 SOMATOM Edge PlusSiemens Medical Solutions USA, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 19 of its ownK190578 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM…Siemens Medical Solutions USA, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 16 of its ownK192061 SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim…Siemens Medical Solutions USA, Inc. · 2019 · Recalled
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K152036SOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · cites it directly28descendants
- K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc. · 2018 · cites it directly20descendants
- K173607SOMATOM Edge PlusSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on20descendants
- K190578SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc. · 2019 · 2 generations on19descendants
- K192061SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan &…Siemens Medical Solutions USA, Inc. · 2019 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K982349 | Somatom Plus 4WITH Volume Zoom CT Scanners | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −5 | K013522 | Somatom P30 CT Systems | Siemens Medical Systems, Inc. | 2001 | 9 |
| −4 | K040665 | Somatom Sensation 64 and Sensation Cardiac | Siemens Medical Solutions USA, Inc. | 2004 | 5 |
| −3 | K081022 | Somatom Definition, Model as/as+ | Siemens Medical Solutions USA, Inc. | 2008 | 3 |
| −2 | K103127 | Somatom Definition as | Siemens Medical Solutions USA, Inc. | 2011 | 6 |
| −1 | K130901 | Somatom Definition as Open | Siemens Medical Systems, Inc. | 2014 | — |
| 0 (this device) | K143401 | SOMATOM Definition Edge | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +1 | K152036 | SOMATOM Definition Edge, SOMATOM Definition AS/AS+ | Siemens Medical Solutions USA, Inc. | 2015 | 4 |
| +1 | K173630 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition… | Siemens Medical Solutions USA, Inc. | 2018 | 4 |
| +2 | K173607 | SOMATOM Edge Plus | Siemens Medical Solutions USA, Inc. | 2018 | 3 |
| +2 | K190578 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition… | Siemens Medical Solutions USA, Inc. | 2019 | 13 |
| +3 | K192061 | SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open… | Siemens Medical Solutions USA, Inc. | 2019 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K120579 | Somatom Definition EdgeSummary page 5…le 1: Predicate Devices Manufacturer Predicate Device 510(k) # Clearance Date Siemens SOMATOM Definition Edge K120579 May 23, 2012 Manufacturer Secondary Device 510(k) # Clearance Date Siemens… | 2012 |
| * | K130901 | Somatom Definition as OpenSummary page 5…0579 May 23, 2012 Manufacturer Secondary Device 510(k) # Clearance Date Siemens SOMATOM Definition AS Open K130901 January 2, 2014 7. Device Description: Siemens intends to market a new software version, syngo® VA48 (SOMARIS/7… | 2014 |
What descends from it? (35)
See all 355 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152036 | SOMATOM Definition Edge, SOMATOM Definition AS/AS+ | 2015 | 28 |
| K173630 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM… | 2018 | 20 |
| K151752 | SOMATOM Emotion 6/16 | 2015 | 2 |
| K151765 | SOMATOM Perspective | 2016 | 0 |
| K151749 | somatom Scope (with syngo CT VC30-easyIQ version), SOMATOM Scope Power (with syngo CT… | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 25, 2019 | Class II | Z-2440-2019 | Software design | SOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in… |
| Jul 13, 2016 | Class II | Z-2626-2016 | Software in the Use Environment | Due to an internal communication error between the firmware and the software of the components, the planned CT scan executes properly, but the injector is not started. Therefore, the contrast agent is not injected and the desired… |
| Aug 14, 2015 | Class II | Z-0019-2016 | Software design | software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction to improve acquisition data in order to optimize… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 8 ancestors have a recall of any class.
- Of its descendants, K152036 (Siemens Medical Solutions USA, Inc., 2015) has gone furthest, with 28 descendants of its own.
- 5 other devices also cite its predicate K120579.
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. 2015, 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 Siemens SOMATOM Definition Edge (Project PA6F) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultancous translation of the patient.)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143401: 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/K143401
Report an extraction error
Are you the manufacturer?
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