510(k) · Cleared
Recalled · Class II · 2020Somatom Definition Flash
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 8, 2012 as substantially equivalent to K082220 (Siemens Medical Solutions USA, Inc., 2008) and 1 other predicate after a 29-day review. Its family tree reaches back 6 generations to 2001. 31 later devices descend from it. It has been recalled 5 times.
- Decided
- May 8, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 6 generations to K013561 (2001). 11 ancestors in all, the oldest K982349 (1998). 31 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 5 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 4 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 3 generations backK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
- 2 generations backK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
- 1 generation backK113342 Somatom Definition FlashSiemens Medical Systems, Inc. · 2011 · Recalled
- This deviceK121072 Somatom Definition FlashSiemens Medical Systems, Inc. · 2012
- Descendant · cites it directly · 29 of its ownK133589 Somatom ForceSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · cites it directly · 27 of its ownK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- Descendant · cites it directly · 25 of its ownK143416 SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 24 of its ownK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 21 of its ownK162302 Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. · 2016 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K133589Somatom ForceSiemens Medical Solutions USA, Inc. · 2014 · cites it directly29descendants
- K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc. · 2015 · cites it directly27descendants
- K143416SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc. · 2015 · cites it directly25descendants
- K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · 2 generations on24descendants
- K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. · 2016 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −5 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −4 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −3 | K052216 | Somatom Definition | Siemens Medical Systems, Inc. | 2005 | — |
| −2 | K082220 | Somatom Flash DS | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −1 | K113342 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2011 | 1 |
| 0 (this device) | K121072 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2012 | — |
| +1 | K133589 | Somatom Force | Siemens Medical Solutions USA, Inc. | 2014 | 9 |
| +1 | K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM… | Siemens Medical Solutions USA, Inc. | 2015 | 16 |
| +1 | K143416 | SOMATOM Definition Flash (VA48) | Siemens Medical Solutions USA, Inc. | 2015 | 5 |
| +2 | K161196 | SOMATOM Drive | Siemens Medical Solutions USA, Inc. | 2016 | 4 |
| +2 | K162302 | Somatom Confidence ® RT Pro | Siemens Medical Solutions USA, Inc. | 2016 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 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 |
|---|---|---|---|
| * | K082220 | Somatom Flash DSSummary page 2…FDA Clearance Date Siemens SOMATOM Definition Flash with SOMARTS7I VA4Q) K082220 10/10/2008 Siemens SOMATOM Definition Flash (with Stellar Detector)… | 2008 |
| * | K113342 | Somatom Definition FlashSummary page 2…K082220 10/10/2008 Siemens SOMATOM Definition Flash (with Stellar Detector) K1 13342 12/29/2011 (with 5OMARIS7/ VA40) 4. Device Description: The Siemens SOMATOM… | 2011 |
| † | K103424 | Safire | 2011 |
What descends from it? (31)
See all 314 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 24, 2020 | Class II | Z-0771-2021 | Software design | System does not trigger a cancel command followed by a reload of the scan with the new parameter(s). This issue may result in a delay in diagnosis and/or need for patient rescan |
| Jun 22, 2020 | Class II | Z-3025-2020 | Software design | Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan |
| Oct 7, 2019 | Class II | Z-0406-2020 | Software design | Software issue identified in the software versions syngo CT VB20 running on the SOMATOM CT Scanner: scan aborts and system crashes |
| Oct 19, 2016 | Class II | Z-0605-2017 | Nonconforming Material/Component | A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by either becoming loose or potentially dropping out.… |
| Mar 2, 2016 | Class II | Z-1520-2016 | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 11 ancestors have a recall of any class.
- Of its descendants, K133589 (Siemens Medical Solutions USA, Inc., 2014) has gone furthest, with 29 descendants of its own.
- 2 other devices also cite its predicate K082220.
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 | — |
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. In addition the SOMATOM Definition Flash is able to produce additional image planes and analysis results by executing optional post processing features, which operate on DICOM images. The images and…
Read the full statement (108 words)
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.
In addition the SOMATOM Definition Flash is able to produce additional image planes and analysis results by executing optional post processing features, which operate on DICOM images.
The images and results delivered by the system can be used by a trained physician as an aid in diagnosis.
(*spiral planes: the axial planes resulting 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/K121072 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121072: Somatom Definition Flash.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121072
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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