510(k) · Cleared
Recalled · Class II · 2016SOMATOM Definition Edge, SOMATOM Definition AS/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 Oct 9, 2015 as substantially equivalent to K143400 (Siemens Medical Solutions USA, Inc., 2015) and 1 other predicate after a 79-day review. Its family tree reaches back 7 generations to 1998. 28 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 9, 2015
- Review
- 79 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 7 generations to K982349 (1998). 10 ancestors in all. 28 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK982349 Somatom Plus 4WITH Volume Zoom CT ScannersSiemens Medical Solutions USA, Inc. · 1998
- 6 generations backK013522 Somatom P30 CT SystemsSiemens Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK040665 Somatom Sensation 64 and Sensation CardiacSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 4 generations backK081022 Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc. · 2008 · Recalled
- 3 generations backK103127 Somatom Definition asSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 2 generations backK130901 Somatom Definition as OpenSiemens Medical Systems, Inc. · 2014
- 1 generation backK143401 SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. · 2015 · Recalled
- This deviceK152036 SOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015
- Descendant · cites it directly · 20 of its ownK173607 SOMATOM Edge PlusSiemens 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 · 3 generations on · 16 of its ownK192061 SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim…Siemens Medical Solutions USA, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 15 of its ownK191891 SOMATOM X.citeSiemens Medical Solutions USA, Inc. · 2019
- Descendant · 4 generations on · 14 of its ownK200524 SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now…Siemens Medical Solutions USA, Inc. · 2020 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K173607SOMATOM Edge PlusSiemens 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
- K192061SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan &…Siemens Medical Solutions USA, Inc. · 2019 · 3 generations on16descendants
- K191891SOMATOM X.citeSiemens Medical Solutions USA, Inc. · 2019 · 3 generations on15descendants
- K200524SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim…Siemens Medical Solutions USA, Inc. · 2020 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K982349 | Somatom Plus 4WITH Volume Zoom CT Scanners | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −6 | K013522 | Somatom P30 CT Systems | Siemens Medical Systems, Inc. | 2001 | 9 |
| −5 | K040665 | Somatom Sensation 64 and Sensation Cardiac | Siemens Medical Solutions USA, Inc. | 2004 | 5 |
| −4 | K081022 | Somatom Definition, Model as/as+ | Siemens Medical Solutions USA, Inc. | 2008 | 3 |
| −3 | K103127 | Somatom Definition as | Siemens Medical Solutions USA, Inc. | 2011 | 6 |
| −2 | K130901 | Somatom Definition as Open | Siemens Medical Systems, Inc. | 2014 | — |
| −1 | K143401 | SOMATOM Definition Edge | Siemens Medical Solutions USA, Inc. | 2015 | 3 |
| 0 (this device) | K152036 | SOMATOM Definition Edge, SOMATOM Definition AS/AS+ | Siemens Medical Solutions USA, Inc. | 2015 | — |
| +1 | K173607 | SOMATOM Edge Plus | Siemens Medical Solutions USA, Inc. | 2018 | 3 |
| +2 | K190578 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition… | Siemens Medical Solutions USA, Inc. | 2019 | 13 |
| +3 | K192061 | SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open… | Siemens Medical Solutions USA, Inc. | 2019 | 2 |
| +3 | K191891 | SOMATOM X.cite | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +4 | K200524 | SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All… | Siemens Medical Solutions USA, Inc. | 2020 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 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? (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 |
|---|---|---|---|
| * | K143400 | SOMATOM Definition AS/AS+Summary page 5…m Classification Panel: Radiology CFR Section: 21 CFR § 892.1750 Device Class: Class II Product Code: 90JAK 510(k) Number: K143400 Legally Marketed Primary Predicate Device (for Device 2) Product Name: SOMATOM P46F Propriety Trade Name: SOMAT… | 2015 |
| * | K143401 | SOMATOM Definition EdgeSummary page 5…m Classification Panel: Radiology CFR Section: 21 CFR § 892.1750 Device Class: Class II Product Code: 90JAK 510(k) Number: K143401 5. Indications for Use SOMATOM Definition AS/AS+ The Siemens SOMATOM Definition AS/AS+ (Project P46) systems are inten… | 2015 |
What descends from it? (28)
See all 282 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-0742-2017 | Software Design Change | Software update that provides software and firmware bug-fixes to improve system performance |
| Nov 15, 2016 | Class II | Z-0744-2017 | Software Design Change | Software update that provides software and firmware bug-fixes to improve system performance |
| Nov 2, 2016 | Class II | Z-0606-2017 | 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… |
| Nov 2, 2016 | Class II | Z-0607-2017 | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 7 of the 10 ancestors have a recall of any class.
- Of its descendants, K173607 (Siemens Medical Solutions USA, Inc., 2018) has gone furthest, with 20 descendants of its own.
- 3 other devices also cite its predicate K143400.
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 Edge, SOMATOM Definition AS/ AS+ (Project P46) systems are intended to
produce cross-sectional images of the body by computer reconstruction of xray 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/K152036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152036: SOMATOM Definition Edge, SOMATOM Definition AS/AS+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152036
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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