510(k) · Cleared
Recalled · Class II · 2013Somatom 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 Dec 29, 2011 as substantially equivalent to K082220 (Siemens Medical Solutions USA, Inc., 2008) after a 45-day review. Its family tree reaches back 5 generations to 2001. 32 later devices descend from it. It has been recalled once.
- Decided
- Dec 29, 2011
- Review
- 45 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K013561 (2001). 10 ancestors in all, the oldest K982349 (1998). 32 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 4 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 3 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 2 generations backK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
- 1 generation backK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
- This deviceK113342 Somatom Definition FlashSiemens Medical Systems, Inc. · 2011
- Descendant · cites it directly · 31 of its ownK121072 Somatom Definition FlashSiemens Medical Systems, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 29 of its ownK133589 Somatom ForceSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 27 of its ownK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 25 of its ownK143416 SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 24 of its ownK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K121072Somatom Definition FlashSiemens Medical Systems, Inc. · 2012 · cites it directly31descendants
- K133589Somatom ForceSiemens Medical Solutions USA, Inc. · 2014 · 2 generations on29descendants
- K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc. · 2015 · 2 generations on27descendants
- K143416SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc. · 2015 · 2 generations on25descendants
- K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −4 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −3 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −2 | K052216 | Somatom Definition | Siemens Medical Systems, Inc. | 2005 | — |
| −1 | K082220 | Somatom Flash DS | Siemens Medical Solutions USA, Inc. | 2008 | — |
| 0 (this device) | K113342 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2011 | — |
| +1 | K121072 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2012 | 5 |
| +2 | K133589 | Somatom Force | Siemens Medical Solutions USA, Inc. | 2014 | 9 |
| +2 | K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM… | Siemens Medical Solutions USA, Inc. | 2015 | 16 |
| +2 | K143416 | SOMATOM Definition Flash (VA48) | Siemens Medical Solutions USA, Inc. | 2015 | 5 |
| +3 | K161196 | SOMATOM Drive | Siemens Medical Solutions USA, Inc. | 2016 | 4 |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (1)
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…rcial distribution: Predicate Device Name FDA Clearance Number FDA Clearance Date Siemens SOMATOM FLASH DS K082220 10/1 0/2008 4. Device Description: The Siemens SOMATOM Definition Flash (with Stellar Detector) is a… | 2008 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121072 | Somatom Definition Flash | 2012 | 31 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 10 ancestors have a recall of any class.
- Of its descendants, K121072 (Siemens Medical Systems, Inc., 2012) has gone furthest, with 31 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. 2011, 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 (with Stellar Detector) 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 (with Stellar Detector) is able to produce additional image planes and analysis results by executing optional post processing…
Read the full statement (114 words)
The Siemens SOMATOM Definition Flash (with Stellar Detector) 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 (with Stellar Detector) 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/K113342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113342: Somatom Definition Flash.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113342
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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