510(k) Report

510(k) · Cleared

Recalled · Class II · 2021

SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence

K190578510(k) TraditionalCleared Jun 27, 2019113-day reviewClass II21 CFR 892.1750Recalls 13

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Siemens Medical Solutions USA, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Jun 27, 2019 as substantially equivalent to K173630 (Siemens Medical Solutions USA, Inc., 2018) and 1 other predicate after a 113-day review. Its family tree reaches back 11 generations to 2001. 19 later devices descend from it. It has been recalled 13 times.

Decided
Jun 27, 2019
Review
113 days
Class
Class II
Product code
JAK
Recalls
13
Predicates
2

Its longest line of descent runs back 11 generations to K013561 (2001). 39 ancestors in all, the oldest K940606 (1994). 19 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2018: 1 other ancestor2016: 1 other ancestor2015: 5 other ancestors2014: 4 other ancestors2012: 3 other ancestors2008: 1 other ancestor1998: 3 other ancestors2011: 1 other ancestor2006: 1 other ancestor2005: 1 other ancestor2004: 2 other ancestors2002: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1994: 1 other ancestor2019: 2 descendants cleared2021: 2 descendants cleared2023: 3 descendants cleared2020: 2 descendants cleared2022: 1 descendant cleared2024: 3 descendants cleared2025: 4 descendants cleared2026: 2 descendants clearedK013561 · Lightspeed 4.0 CT Scanner System · GE Medical Systems · 2001 · recalledK030420 · Lightspeed 5.0 Computed Tomography System · GE Medical Systems · 2003 · recalledK040372 · Lightspeed 7.0 CT Scanner System · Ge Medical Systems, LLC · 2004 · recalledK052216 · Somatom Definition · Siemens Medical Systems, Inc. · 2005K082220 · Somatom Flash DS · Siemens Medical Solutions USA, Inc. · 2008×2: 2 generations cleared close together, K113342 (2011), K121072 (2012) K133589 · Somatom Force · Siemens Medical Solutions USA, Inc. · 2014 · recalledK142955 · SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power · Siemens Medical Solutions USA, Inc. · 2015 · recalledK161196 · SOMATOM Drive · Siemens Medical Solutions USA, Inc. · 2016 · recalledK173630 · SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence · Siemens Medical Solutions USA, Inc. · 2018 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 6 other ancestors3 generations back: 9 other ancestors4 generations back: 5 other ancestors5 generations back: 4 other ancestors6 generations back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 4 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K173630 · SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence · Siemens Medical Solutions USA, Inc. · 2018 · recalledK161196 · SOMATOM Drive · Siemens Medical Solutions USA, Inc. · 2016 · recalledK142955 · SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power · Siemens Medical Solutions USA, Inc. · 2015 · recalledK133589 · Somatom Force · Siemens Medical Solutions USA, Inc. · 2014 · recalledK121072 · Somatom Definition Flash · Siemens Medical Systems, Inc. · 2012 · recalledK113342 · Somatom Definition Flash · Siemens Medical Systems, Inc. · 2011 · recalledK082220 · Somatom Flash DS · Siemens Medical Solutions USA, Inc. · 2008K052216 · Somatom Definition · Siemens Medical Systems, Inc. · 2005K040372 · Lightspeed 7.0 CT Scanner System · Ge Medical Systems, LLC · 2004 · recalledK030420 · Lightspeed 5.0 Computed Tomography System · GE Medical Systems · 2003 · recalledK013561 · Lightspeed 4.0 CT Scanner System · GE Medical Systems · 2001 · recalled−10−50+5
  1. Root · 11 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
  2. 7 generations between
  3. 3 generations backK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
  4. 2 generations backK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · Recalled
  5. 1 generation backK173630 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM…Siemens Medical Solutions USA, Inc. · 2018 · Recalled
  6. This deviceK190578 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM…Siemens Medical Solutions USA, Inc. · 2019
  7. Descendant · cites it directly · 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
  8. Descendant · cites it directly · 15 of its ownK191891 SOMATOM X.citeSiemens Medical Solutions USA, Inc. · 2019
  9. Descendant · 2 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
  10. Descendant · 3 generations on · 12 of its ownK211373 SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All…Siemens Medical Solutions USA, Inc. · 2021 · Recalled
  11. Descendant · 4 generations on · 5 of its ownK233650 SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top…Siemens Medical Solutions USA, Inc. · 2024 · Recalled
Show all 11 generations
  1. Root · 11 generations backK013561 Lightspeed 4.0 CT Scanner SystemGE Medical Systems · 2001 · Recalled
  2. 10 generations backK030420 Lightspeed 5.0 Computed Tomography SystemGE Medical Systems · 2003 · Recalled
  3. 9 generations backK040372 Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC · 2004 · Recalled
  4. 8 generations backK052216 Somatom DefinitionSiemens Medical Systems, Inc. · 2005
  5. 7 generations backK082220 Somatom Flash DSSiemens Medical Solutions USA, Inc. · 2008
  6. 6 generations backK113342 Somatom Definition FlashSiemens Medical Systems, Inc. · 2011 · Recalled
  7. 5 generations backK121072 Somatom Definition FlashSiemens Medical Systems, Inc. · 2012 · Recalled
  8. 4 generations backK133589 Somatom ForceSiemens Medical Solutions USA, Inc. · 2014 · Recalled
  9. 3 generations backK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
  10. 2 generations backK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · Recalled
  11. 1 generation backK173630 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM…Siemens Medical Solutions USA, Inc. · 2018 · Recalled
  12. This deviceK190578 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM…Siemens Medical Solutions USA, Inc. · 2019

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2019: 22020: 22021: 22022: 12023: 32024: 32025: 42026: 2
2019high 4 (2025) · low 1 (2022)2026

Most influential descendants

Showing 5 of 19 · See all
  • K192061SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan &…Siemens Medical Solutions USA, Inc. · 2019 · cites it directly16descendants
  • K191891SOMATOM X.citeSiemens Medical Solutions USA, Inc. · 2019 · cites it directly15descendants
  • K200524SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim…Siemens Medical Solutions USA, Inc. · 2020 · 2 generations on14descendants
  • K211373SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X.…Siemens Medical Solutions USA, Inc. · 2021 · 3 generations on12descendants
  • K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM…Siemens Medical Solutions USA, Inc. · 2024 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K013561Lightspeed 4.0 CT Scanner SystemGE Medical Systems20015
−10K030420Lightspeed 5.0 Computed Tomography SystemGE Medical Systems20034
−9K040372Lightspeed 7.0 CT Scanner SystemGe Medical Systems, LLC20045
−8K052216Somatom DefinitionSiemens Medical Systems, Inc.2005—
−7K082220Somatom Flash DSSiemens Medical Solutions USA, Inc.2008—
−6K113342Somatom Definition FlashSiemens Medical Systems, Inc.20111
−5K121072Somatom Definition FlashSiemens Medical Systems, Inc.20125
−4K133589Somatom ForceSiemens Medical Solutions USA, Inc.20149
−3K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.201516
−2K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.20164
−1K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20184
0 (this device)K190578SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition…Siemens Medical Solutions USA, Inc.2019—
+1K192061SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open…Siemens Medical Solutions USA, Inc.20192
+1K191891SOMATOM X.citeSiemens Medical Solutions USA, Inc.2019—
+2K200524SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All…Siemens Medical Solutions USA, Inc.20207
+3K211373SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM…Siemens Medical Solutions USA, Inc.20213
+4K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim…Siemens Medical Solutions USA, Inc.20241

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199830
199910
200010
200110
200210
200420
200510
200610
200810
201110
201230
201440
201550
201610
201810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201920
202020
202120
202210
202330
202430
202540
202620
FIG. 1 — Lineage of K190578, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…
Summary page 13
…Page 2 of 12 III. Predicate Device Primary Predicate Device: Trade Name: SOMATOM CT Scanner Systems 510(k) Number: K173630 Clearance Date: March 30, 2018 Classification Name: Computed Tomography X-ray System Classification Panel: Rad…
Siemens Medical Solutions USA, Inc.20184
*K173607SOMATOM Edge Plus
Summary page 13
…redicate device recalls have been considered in the subject device design. Predicate Device: Trade Name: SOMATOM Edge Plus 510(k) Number: K173607 Clearance Date: March 21, 2018 Classification Name: Computed Tomography X-ray System Classification Panel:…
Siemens Medical Solutions USA, Inc.20183

What descends from it? (19)

See all 19

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K192061SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan &…Siemens Medical Solutions USA, Inc.201916
K191891SOMATOM X.citeSiemens Medical Solutions USA, Inc.201915
K211591NAEOTOM Alpha, Scan&GOSiemens Medical Solutions USA, Inc.20214
K230421SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20233

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 19, 2021Class IIZ-0472-2022Software Design ChangeSoftware version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Nov 19, 2021Class IIZ-0474-2022Software Design ChangeSoftware version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Nov 19, 2021Class IIZ-0473-2022Software Design ChangeSoftware version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Nov 19, 2021Class IIZ-0475-2022Software Design ChangeSoftware version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Aug 30, 2021Class IIZ-0283-2022Software designsoftware syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the…
Aug 30, 2021Class IIZ-0288-2022Software designsoftware syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the…
Aug 30, 2021Class IIZ-0284-2022Software designsoftware syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the…
Aug 30, 2021Class IIZ-0289-2022Software designsoftware syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the…
Aug 30, 2021Class IIZ-0285-2022Software designsoftware syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the…
Aug 30, 2021Class IIZ-0286-2022Software designsoftware syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the…
Aug 30, 2021Class IIZ-0287-2022Software designsoftware syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the…
Jul 25, 2019Class IIZ-2440-2019Software designSOMATOM Definition Edge, SOMATOM Definition AS, SOMATOM Definition Flash with software syngo.CT with Software version VA48A_SP5 may result in scanning workflow interruptions and unexpected user notifications. and may result in a delay in…
Jul 3, 2019Class IIZ-2270-2019Software designPotential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

The 5 latest of 13 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 18 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
  • 32 of the 39 ancestors have a recall of any class.
  • Of its descendants, K192061 (Siemens Medical Solutions USA, Inc., 2019) has gone furthest, with 16 descendants of its own.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · JAK

27in 2025

2007: 142008: 262009: 152010: 72011: 162012: 282013: 172014: 302015: 302016: 252017: 292018: 242019: 282020: 302021: 202022: 302023: 272024: 262025: 272026 (partial year): 21
2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007: 27 days median2008: 42 days median2009: 31 days median2010: 92 days median2011: 155 days median2012: 121 days median2013: 132 days median2014: 200 days median2015: 140 days median2016: 129 days median2017: 96 days median2018: 114 days median2019: 94 days median2020: 112 days median2021: 145 days median2022: 131 days median2023: 139 days median2024: 141 days median2025: 141 days median2026 (partial year): 167 days median
2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007: 112008: 162009: 292010: 512011: 342012: 232013: 112014: 102015: 282016: 442017: 332018: 102019: 52020: 82021: 152022: 92023: 92024: 202025: 172026 (partial year): 23
2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007: 762008: 1202009: 1052010: 1192011: 2052012: 1922013: 4142014: 3082015: 4542016: 3652017: 3382018: 5432019: 2332020: 1772021: 2612022: 1992023: 3102024: 2122025: 219
2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200714271176
2008264216120
2009153129105
201079251119
20111615534205
20122812123192
20131713211414
20143020010308
20153014028454
20162512944365
2017299633338
20182411410543
201928945233
2020301128177
20212014515261
2022301319199
2023271399310
20242614120212
20252714117219
20262116723—

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 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…

Read the full statement (110 words)

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.

Indications for use as stated in the FDA summary.

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798 FDA decisions under this applicant name. See the company

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  • P140011/S009MAMMOMAT B.brilliant with Tomosynthesis OptionSiemens Medical Solutions USA, Inc. · 2026
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Recent decisions in JAK

The JAK category page

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  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
  • K253836FCT iStream Phase 2Fujifilm Corporation · 2026

https://510kreport.com/device/K190578 · printed Nov 6, 2026

Cite this page

510(k) Report. “K190578: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190578

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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