510(k) · Cleared
ClearedNAEOTOM Alpha, Scan&GO
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 Sep 30, 2021 as substantially equivalent to K190578 (Siemens Medical Solutions USA, Inc., 2019) and 1 other predicate after a 129-day review. Its family tree reaches back 14 generations to 2001. 4 later devices descend from it.
- Decided
- Sep 30, 2021
- Review
- 129 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K013561 (2001). 46 ancestors in all, the oldest K940606 (1994). 4 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 10 generations between
- 3 generations backK173632 SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc. · 2018 · Recalled
- 2 generations backK191891 SOMATOM X.citeSiemens Medical Solutions USA, Inc. · 2019
- 1 generation backK200524 SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now…Siemens Medical Solutions USA, Inc. · 2020 · Recalled
- This deviceK211591 NAEOTOM Alpha, Scan&GOSiemens Medical Solutions USA, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK220814 NAEOTOM Alpha, Scan&GO SoftwareSiemens Medical Solutions USA, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 2 of its ownK233657 NAEOTOM AlphaSiemens Medical Solutions USA, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK243523 NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM…Siemens Medical Solutions USA, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK251061 NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM…Siemens Medical Solutions USA, Inc. · 2025 · Recalled
Show all 14 generations
- Root · 14 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
- 13 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
- 12 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
- 11 generations backK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
- 10 generations backK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
- 9 generations backK113342 Somatom Definition FlashSiemens Medical Systems, Inc. · 2011 · Recalled
- 8 generations backK121072 Somatom Definition FlashSiemens Medical Systems, Inc. · 2012 · Recalled
- 7 generations backK133589 Somatom ForceSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 6 generations backK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
- 5 generations backK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · Recalled
- 4 generations backK163296 SOMATOM go.Up, SOMATOM go.NowSiemens Medical Solutions USA, Inc. · 2017 · Recalled
- 3 generations backK173632 SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOSiemens Medical Solutions USA, Inc. · 2018 · Recalled
- 2 generations backK191891 SOMATOM X.citeSiemens Medical Solutions USA, Inc. · 2019
- 1 generation backK200524 SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now…Siemens Medical Solutions USA, Inc. · 2020 · Recalled
- This deviceK211591 NAEOTOM Alpha, Scan&GOSiemens Medical Solutions USA, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K220814NAEOTOM Alpha, Scan&GO SoftwareSiemens Medical Solutions USA, Inc. · 2022 · cites it directly3descendants
- K233657NAEOTOM AlphaSiemens Medical Solutions USA, Inc. · 2024 · 2 generations on2descendants
- K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc. · 2025 · 3 generations on1descendant
- K251061NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeSiemens Medical Solutions USA, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K013561 | Lightspeed 4.0 CT Scanner System | GE Medical Systems | 2001 | 5 |
| −13 | K030420 | Lightspeed 5.0 Computed Tomography System | GE Medical Systems | 2003 | 4 |
| −12 | K040372 | Lightspeed 7.0 CT Scanner System | Ge Medical Systems, LLC | 2004 | 5 |
| −11 | K052216 | Somatom Definition | Siemens Medical Systems, Inc. | 2005 | — |
| −10 | K082220 | Somatom Flash DS | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −9 | K113342 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2011 | 1 |
| −8 | K121072 | Somatom Definition Flash | Siemens Medical Systems, Inc. | 2012 | 5 |
| −7 | K133589 | Somatom Force | Siemens Medical Solutions USA, Inc. | 2014 | 9 |
| −6 | K142955 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM… | Siemens Medical Solutions USA, Inc. | 2015 | 16 |
| −5 | K161196 | SOMATOM Drive | Siemens Medical Solutions USA, Inc. | 2016 | 4 |
| −4 | K163296 | SOMATOM go.Up, SOMATOM go.Now | Siemens Medical Solutions USA, Inc. | 2017 | 6 |
| −3 | K173632 | SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO | Siemens Medical Solutions USA, Inc. | 2018 | 18 |
| −2 | K191891 | SOMATOM X.cite | Siemens Medical Solutions USA, Inc. | 2019 | — |
| −1 | K200524 | SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All… | Siemens Medical Solutions USA, Inc. | 2020 | 7 |
| 0 (this device) | K211591 | NAEOTOM Alpha, Scan&GO | Siemens Medical Solutions USA, Inc. | 2021 | — |
| +1 | K220814 | NAEOTOM Alpha, Scan&GO Software | Siemens Medical Solutions USA, Inc. | 2022 | 1 |
| +2 | K233657 | NAEOTOM Alpha | Siemens Medical Solutions USA, Inc. | 2024 | — |
| +3 | K243523 | NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | 2025 | — |
| +4 | K251061 | NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime | Siemens Medical Solutions USA, Inc. | 2025 | 3 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K190578 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Summary page 5…JAK Secondary Product Code: LLZ III. Predicate Device Primary Predicate Device: Trade Name: SOMATOM Force 510(k) Number: K190578 Clearance Date: June 27, 2019 Classification Name: Computed Tomography X-ray System Classification Panel: Radiology… | 2019 |
| * | K200524 | SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim…Summary page 5…been considered in the subject device design. Secondary Predicate Device: Trade Name: SOMATOM X.cite, Scan&GO 510(k) Number: K200524 Clearance Date: April 01, 2020 Classification Name: Computed Tomography X-ray System Classification Panel: Radiology… | 2020 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220814 | NAEOTOM Alpha, Scan&GO Software | 2022 | 3 |
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 20 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 37 of the 46 ancestors have a recall of any class.
- Of its descendants, K220814 (Siemens Medical Solutions USA, Inc., 2022) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K190578.
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. 2021, 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?
NAEOTOM Alpha 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 physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung…
Read the full statement (182 words)
NAEOTOM Alpha
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 physician as an aid in diagnosis.
The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
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.
Scan&GO
This in-room scan application is a planning and information system designed to perform the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.
The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211591: NAEOTOM Alpha, Scan&GO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211591
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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