510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Somatom Spirit

K042328510(k) TraditionalCleared Sep 14, 200418-day reviewClass II21 CFR 892.1750Recalls 2

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

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

Cleared on Sep 14, 2004 as substantially equivalent to K003014 (Siemens Medical Solutions USA, Inc., 2000) and 1 other predicate after an 18-day review. Its family tree reaches back 2 generations to 1994. 30 later devices descend from it. It has been recalled 2 times.

Decided
Sep 14, 2004
Review
18 days
Class
Class II
Product code
JAK
Recalls
2
Predicates
2

Its longest line of descent runs back 2 generations to K940606 (1994). 5 ancestors in all. 30 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1998: 2 other ancestors2014: 1 descendant cleared2015: 1 descendant cleared2016: 3 descendants cleared2018: 2 descendants cleared2017: 3 descendants cleared2019: 3 descendants cleared2021: 2 descendants cleared2023: 3 descendants cleared2020: 2 descendants cleared2022: 1 descendant cleared2024: 3 descendants cleared2025: 4 descendants cleared2026: 2 descendants clearedK940606 · Hispeed Advantage II · GE Medical Systems · 1994K991716 · Hispeed NX/I CT Scanner System · Ge Medical Systems, Inc. · 1999 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 5 descendants4 generations forward: 3 descendants5 generations forward: 4 descendants6 generations forward: 4 descendants7 generations forward: 3 descendants8 generations forward: 4 descendants9 generations forward: 3 descendants10 generations forward: 1 descendant K991716 · Hispeed NX/I CT Scanner System · Ge Medical Systems, Inc. · 1999 · recalledK940606 · Hispeed Advantage II · GE Medical Systems · 19940+5+10
  1. Root · 2 generations backK940606 Hispeed Advantage IIGE Medical Systems · 1994
  2. 1 generation backK991716 Hispeed NX/I CT Scanner SystemGe Medical Systems, Inc. · 1999 · Recalled
  3. This deviceK042328 Somatom SpiritSiemens Medical Systems, Inc. · 2004
  4. Descendant · cites it directly · 29 of its ownK140912 Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc. · 2014 · Recalled
  5. Descendant · 2 generations on · 27 of its ownK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
  6. Descendant · 3 generations on · 24 of its ownK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · Recalled
  7. Descendant · 3 generations on · 21 of its ownK162302 Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. · 2016 · Recalled
  8. Descendant · 3 generations on · 20 of its ownK173630 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM…Siemens Medical Solutions USA, Inc. · 2018 · Recalled

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12016: 32017: 32018: 22019: 32020: 22021: 22022: 12023: 32024: 32025: 42026: 2
2014high 4 (2025) · low 1 (2014)2026

Most influential descendants

Showing 5 of 30 · See all
  • K140912Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc. · 2014 · cites it directly29descendants
  • K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc. · 2015 · 2 generations on27descendants
  • K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · 3 generations on24descendants
  • K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. · 2016 · 3 generations on21descendants
  • K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc. · 2018 · 3 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K940606Hispeed Advantage IIGE Medical Systems1994—
−1K991716Hispeed NX/I CT Scanner SystemGe Medical Systems, Inc.19992
0 (this device)K042328Somatom SpiritSiemens Medical Systems, Inc.2004—
+1K140912Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc.20142
+2K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.201516
+3K161196SOMATOM DriveSiemens Medical Solutions USA, Inc.20164
+3K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc.20161
+3K173630SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition…Siemens Medical Solutions USA, Inc.20184

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201630
201730
201820
201930
202020
202120
202210
202330
202430
202540
202620
FIG. 1 — Lineage of K042328, 1994–2026Source: 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
*K003014Somatom Emotion MS
Summary page 2
…equivalent to the following systems: Product Name 510(k) Clearance Date K003014 10/12/00 [_ Siemens Emotion Duo K991716…
Siemens Medical Solutions USA, Inc.20001
*K991716Hispeed NX/I CT Scanner System
Summary page 2
…learance Date K003014 10/12/00 [_ Siemens Emotion Duo K991716 06/18/99 General Electric s HiSpeed NX/i…
Ge Medical Systems, Inc.19992

What descends from it? (30)

See all 30

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140912Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc.201429

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 15, 2018Class IIZ-1451-2018Software designto inform customers of possible incorrect tube current calculations by the CARE Dose4D algorithm for head scans based on p.a. (posterior-anterior) or a.p. (anterior-posterior) topograms. Depending on the geometrical shape of the skull…
Mar 21, 2014Class IIZ-1721-2014Component design/selectionThe rubber damper may degrade and break, causing loosening of the motor mounting plates, which could lead to a series of events that could place the operator and patient at risk of injury.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
  • 3 of the 5 ancestors have a recall of any class.
  • Of its descendants, K140912 (Siemens Medical Solutions USA, Inc., 2014) has gone furthest, with 29 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.

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?

The SOMATOM Spirit system is 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 angels 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.

More from Siemens Medical Systems, Inc.

25 FDA decisions under this applicant name. See the company

  • K133646AdmireSiemens Medical Systems, Inc. · 2014
  • K130901Somatom Definition as OpenSiemens Medical Systems, Inc. · 2014
  • K123540Syngo CT Pulmo 3DSiemens Medical Systems, Inc. · 2013
  • K123541Syngo.CT Neuro PerfusionSiemens Medical Systems, Inc. · 2013
  • K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc. · 2012

Recent decisions in JAK

The JAK category page

  • K260391AVIEW Aorta MetricsCoreline Soft Co., Ltd. · 2026
  • K261225CAS-One IRCascination AG · 2026
  • K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp. · 2026
  • K261229SCENARIA View Phase 6.0Fujifilm Corporation · 2026
  • K253836FCT iStream Phase 2Fujifilm Corporation · 2026

https://510kreport.com/device/K042328 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042328: Somatom Spirit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042328

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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