510(k) · Cleared
Recalled · Class II · 2025NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
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 Jul 28, 2025 as substantially equivalent to K243523 (Siemens Medical Solutions USA, Inc., 2025) after a 115-day review. Its family tree reaches back 18 generations to 2001. It has been recalled 3 times.
- Decided
- Jul 28, 2025
- Review
- 115 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 18 generations to K013561 (2001). 53 ancestors in all, the oldest K940606 (1994). No later device cites it as a predicate yet.
- Root · 18 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 14 generations between
- 3 generations backK220814 NAEOTOM Alpha, Scan&GO SoftwareSiemens Medical Solutions USA, Inc. · 2022 · Recalled
- 2 generations backK233657 NAEOTOM AlphaSiemens Medical Solutions USA, Inc. · 2024
- 1 generation backK243523 NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM…Siemens Medical Solutions USA, Inc. · 2025
- This deviceK251061 NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM…Siemens Medical Solutions USA, Inc. · 2025
Show all 18 generations
- Root · 18 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 17 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 16 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 15 generations backK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
- 14 generations backK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
- 13 generations backK113342 Somatom Definition FlashSiemens Medical Systems, Inc. · 2011 · Recalled
- 12 generations backK121072 Somatom Definition FlashSiemens Medical Systems, Inc. · 2012 · Recalled
- 11 generations backK133589 Somatom ForceSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 10 generations backK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- 9 generations backK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- 8 generations backK163296 SOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc. · 2017 · Recalled
- 7 generations backK173632 SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc. · 2018 · Recalled
- 6 generations backK191891 SOMATOM X.citeSiemens Medical Solutions USA, Inc. · 2019
- 5 generations backK200524 SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now…Siemens Medical Solutions USA, Inc. · 2020 · Recalled
- 4 generations backK211373 SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All…Siemens Medical Solutions USA, Inc. · 2021 · Recalled
- 3 generations backK220814 NAEOTOM Alpha, Scan&GO SoftwareSiemens Medical Solutions USA, Inc. · 2022 · Recalled
- 2 generations backK233657 NAEOTOM AlphaSiemens Medical Solutions USA, Inc. · 2024
- 1 generation backK243523 NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM…Siemens Medical Solutions USA, Inc. · 2025
- This deviceK251061 NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM…Siemens Medical Solutions USA, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −17 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −16 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −15 | K052216 | Somatom Definition | Siemens Medical Systems, Inc. | 2005 | — |
| −14 | K082220 | Somatom Flash DS | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −13 | K113342 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2011 | 1 |
| −12 | K121072 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2012 | 5 |
| −11 | K133589 | Somatom Force | Siemens Medical Solutions USA, Inc. | 2014 | 9 |
| −10 | K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM… | Siemens Medical Solutions USA, Inc. | 2015 | 16 |
| −9 | K161196 | SOMATOM Drive | Siemens Medical Solutions USA, Inc. | 2016 | 4 |
| −8 | K163296 | SOMATOM go.Up, SOMATOM go.Now | Siemens Medical Solutions USA, Inc. | 2017 | 6 |
| −7 | K173632 | SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO | Siemens Medical Solutions USA, Inc. | 2018 | 18 |
| −6 | K191891 | SOMATOM X.cite | Siemens Medical Solutions USA, Inc. | 2019 | — |
| −5 | K200524 | SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All… | Siemens Medical Solutions USA, Inc. | 2020 | 7 |
| −4 | K211373 | SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM… | Siemens Medical Solutions USA, Inc. | 2021 | 3 |
| −3 | K220814 | NAEOTOM Alpha, Scan&GO Software | Siemens Medical Solutions USA, Inc. | 2022 | 1 |
| −2 | K233657 | NAEOTOM Alpha | Siemens Medical Solutions USA, Inc. | 2024 | — |
| −1 | K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | 2025 | — |
| 0 (this device) | K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSummary page 6…III. Predicate Device Predicate Device: Trade Name: NAEOTOM Alpha class CT systems with SOMARIS/10 syngo CT VB20 510(k) Number: K243523 Clearance Date: February 12, 2025 Classification Name: Computed Tomography X-ray System Classifica… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2025 | Class II | Z-1240-2026 | Under Investigation by firm | To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. |
| Dec 19, 2025 | Class II | Z-1241-2026 | Under Investigation by firm | To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. |
| Dec 19, 2025 | Class II | Z-1242-2026 | Under Investigation by firm | To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 40 of the 53 ancestors have a recall of any class.
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. 2025, 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?
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.
This CT system can be used for low dose lung cancer screening in high risk populations*.
* As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251061: NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251061
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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