510(k) · Cleared
ClearedSomatom Flash DS
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 Oct 10, 2008 as substantially equivalent to K081022 (Siemens Medical Solutions USA, Inc., 2008) and 1 other predicate after a 65-day review. Its family tree reaches back 4 generations to 2001. 36 later devices descend from it.
- Decided
- Oct 10, 2008
- Review
- 65 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K013561 (2001). 9 ancestors in all, the oldest K982349 (1998). 36 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 3 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 2 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 1 generation backK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
- This deviceK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
- Descendant · cites it directly · 32 of its ownK113342 Somatom Definition FlashSiemens Medical Systems, Inc. · 2011 · Recalled
- 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
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K113342Somatom Definition FlashSiemens Medical Systems, Inc. · 2011 · cites it directly32descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −3 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −2 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −1 | K052216 | Somatom Definition | Siemens Medical Systems, Inc. | 2005 | — |
| 0 (this device) | K082220 | Somatom Flash DS | Siemens Medical Solutions USA, Inc. | 2008 | — |
| +1 | K113342 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2011 | 1 |
| +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 |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 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 |
|---|---|---|---|
| * | K081022 | Somatom Definition, Model as/as+Summary page 2…rcial distribution: Predicate Device Name FDA ClearanceNumber FDA Clearance Date Siemens SOMATOM Definition AS/AS+ K081022 06/05/2008 Siemens SOMATOM Definition K052216 09/08/2005 4. Device… | 2008 |
| * | K052216 | Somatom DefinitionSummary page 2…umber FDA Clearance Date Siemens SOMATOM Definition AS/AS+ K081022 06/05/2008 Siemens SOMATOM Definition K052216 09/08/2005 4. Device Description: The Siemens SOMATOM P47 is a Computed Tomography X- ray System, wh… | 2005 |
What descends from it? (36)
See all 363 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 9 ancestors have a recall of any class.
- Of its descendants, K113342 (Siemens Medical Systems, Inc., 2011) has gone furthest, with 32 descendants of its own.
- 3 other devices also cite its predicate K081022.
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. 2008, 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 P47 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 P47 is able to produce additional image planes and analysis results by executing optional postprocessing 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/K082220 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082220: Somatom Flash DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082220
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