510(k) · Cleared
Recalled · Class II · 2016SOMATOM Definition Flash (VA48)
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 16, 2015 as substantially equivalent to K121072 (Siemens Medical Systems, Inc., 2012) and 1 other predicate after a 139-day review. Its family tree reaches back 7 generations to 2001. 25 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 16, 2015
- Review
- 139 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 7 generations to K013561 (2001). 14 ancestors in all, the oldest K982349 (1998). 25 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 6 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 5 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 4 generations backK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
- 3 generations backK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
- 2 generations backK113342 Somatom Definition FlashSiemens Medical Systems, Inc. · 2011 · Recalled
- 1 generation backK121072 Somatom Definition FlashSiemens Medical Systems, Inc. · 2012 · Recalled
- This deviceK143416 SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc. · 2015
- Descendant · cites it directly · 24 of its ownK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · 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 · 19 of its ownK190578 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM…Siemens Medical Solutions USA, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 19 of its ownK163297 Scan&GOSiemens Medical Solutions USA, Inc. · 2017
- Descendant · 2 generations on · 19 of its ownK163296 SOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc. · 2017 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · cites it directly24descendants
- K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc. · 2018 · cites it directly20descendants
- K190578SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc. · 2019 · 2 generations on19descendants
- K163297Scan&GOSiemens Medical Solutions USA, Inc. · 2017 · 2 generations on19descendants
- K163296SOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc. · 2017 · 2 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −6 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −5 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −4 | K052216 | Somatom Definition | Siemens Medical Systems, Inc. | 2005 | — |
| −3 | K082220 | Somatom Flash DS | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −2 | K113342 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2011 | 1 |
| −1 | K121072 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2012 | 5 |
| 0 (this device) | K143416 | SOMATOM Definition Flash (VA48) | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +1 | K161196 | SOMATOM Drive | Siemens Medical Solutions USA, Inc. | 2016 | 4 |
| +1 | K173630 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition… | Siemens Medical Solutions USA, Inc. | 2018 | 4 |
| +2 | K190578 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition… | Siemens Medical Solutions USA, Inc. | 2019 | 13 |
| +2 | K163297 | Scan&GO | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +2 | K163296 | SOMATOM go.Up, SOMATOM go.Now | Siemens Medical Solutions USA, Inc. | 2017 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 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 |
|---|---|---|---|
| * | K121072 | Somatom Definition FlashSummary page 4…Trade Name: SOMATOM Definition Flash with Stellar Detector (SOMARIS/7 VA44) 510(k) #: K121072 Clearance Date: May 8, 2012 Classification Name: Computed Tomography X-ray System Classi… | 2012 |
| * | K130901 | Somatom Definition as OpenSummary page 5…subject of any design related recalls. Trade Name: SOMATOM Definition AS Open (VA46) 510(k) #: K130901 Clearance Date: January 2, 2014 Classification Name: Computed Tomography X-ray System… | 2014 |
What descends from it? (25)
See all 252 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 15, 2016 | Class II | Z-0743-2017 | Software Design Change | Software update that provides software and firmware bug-fixes to improve system performance |
| Nov 2, 2016 | Class II | Z-0608-2017 | Software design | Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash Systems with software version VA48A_SP2 and Care… |
| Oct 19, 2016 | Class II | Z-0374-2017 | Nonconforming Material/Component | Hardware issue that may expose the user to a potential risk for serious injury due to exposure to rotating or electrical parts. |
| Jul 13, 2016 | Class II | Z-2625-2016 | 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-0020-2016 | 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 14 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 9 of the 14 ancestors have a recall of any class.
- Of its descendants, K161196 (Siemens Medical Solutions USA, Inc., 2016) has gone furthest, with 24 descendants of its own.
- 3 other devices also cite its predicate K121072.
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 Flash system is 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 simultaneous translation of the patient.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143416: SOMATOM Definition Flash (VA48).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143416
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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