510(k) · Cleared
Recalled · Class II · 2020Somatom Definition as
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 Mar 4, 2011 as substantially equivalent to K081022 (Siemens Medical Solutions USA, Inc., 2008) after a 133-day review. Its family tree reaches back 4 generations to 1998. 53 later devices descend from it. It has been recalled 6 times.
- Decided
- Mar 4, 2011
- Review
- 133 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 4 generations to K982349 (1998). 5 ancestors in all. 53 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK982349 Somatom Plus 4WITH Volume Zoom CT ScannersSiemens Medical Solutions USA, Inc. · 1998
- 3 generations backK013522 Somatom P30 CT SystemsSiemens Medical Systems, Inc. · 2001 · Recalled
- 2 generations backK040665 Somatom Sensation 64 and Sensation CardiacSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 1 generation backK081022 Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- This deviceK103127 Somatom Definition asSiemens Medical Solutions USA, Inc. · 2011
- Descendant · cites it directly · 49 of its ownK130901 Somatom Definition as OpenSiemens Medical Systems, Inc. · 2014
- Descendant · 2 generations on · 35 of its ownK143401 SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 32 of its ownK143400 SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 28 of its ownK152036 SOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 27 of its ownK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K130901Somatom Definition as OpenSiemens Medical Systems, Inc. · 2014 · cites it directly49descendants
- K143401SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. · 2015 · 2 generations on35descendants
- K143400SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · 2 generations on32descendants
- K152036SOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · 3 generations on28descendants
- K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc. · 2015 · 2 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982349 | Somatom Plus 4WITH Volume Zoom CT Scanners | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −3 | K013522 | Somatom P30 CT Systems | Siemens Medical Systems, Inc. | 2001 | 9 |
| −2 | K040665 | Somatom Sensation 64 and Sensation Cardiac | Siemens Medical Solutions USA, Inc. | 2004 | 5 |
| −1 | K081022 | Somatom Definition, Model as/as+ | Siemens Medical Solutions USA, Inc. | 2008 | 3 |
| 0 (this device) | K103127 | Somatom Definition as | Siemens Medical Solutions USA, Inc. | 2011 | — |
| +1 | K130901 | Somatom Definition as Open | Siemens Medical Systems, Inc. | 2014 | — |
| +2 | K143401 | SOMATOM Definition Edge | Siemens Medical Solutions USA, Inc. | 2015 | 3 |
| +2 | K143400 | SOMATOM Definition AS/AS+ | Siemens Medical Solutions USA, Inc. | 2015 | 5 |
| +3 | K152036 | SOMATOM Definition Edge, SOMATOM Definition AS/AS+ | Siemens Medical Solutions USA, Inc. | 2015 | 4 |
| +2 | K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM… | Siemens Medical Solutions USA, Inc. | 2015 | 16 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 8 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 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? (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 |
|---|---|---|---|
| * | K081022 | Somatom Definition, Model as/as+Summary page 2…stribution: Predicate Device Name = FDA Clearance Number FDA Clearance Date Siemens SOMATOM Definition AS/AS+ K08 1022 06/05/2008 7. Summary of Technological Characteristics of the Principal Device as Compared with t… | 2008 |
What descends from it? (53)
See all 532 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 |
| Jul 3, 2019 | Class II | Z-2268-2019 | Software design | Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort. |
| Feb 14, 2019 | Class II | Z-1247-2019 | Software design | Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to a software issue found in syngo CT VB10A for the Siemens Healthineers CT scanners with a single X-ray tube. |
| 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. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K130901 (Siemens Medical Systems, Inc., 2014) has gone furthest, with 49 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. 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 AS Open 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 simultaneous translation of the patient.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103127: Somatom Definition as.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103127
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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