510(k) Report

510(k) · Cleared

Cleared

Somatom Definition as Open

K130901510(k) TraditionalCleared Jan 2, 2014276-day reviewClass II21 CFR 892.1750

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 Jan 2, 2014 as substantially equivalent to K103127 (Siemens Medical Solutions USA, Inc., 2011) after a 276-day review. Its family tree reaches back 5 generations to 1998. 49 later devices descend from it.

Decided
Jan 2, 2014
Review
276 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K982349 (1998). 6 ancestors in all. 49 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2015: 8 descendants cleared2016: 6 descendants cleared2018: 4 descendants cleared2017: 5 descendants cleared2019: 4 descendants cleared2020: 3 descendants cleared2021: 2 descendants cleared2023: 4 descendants cleared2022: 2 descendants cleared2024: 3 descendants cleared2025: 6 descendants cleared2026: 2 descendants clearedK982349 · Somatom Plus 4WITH Volume Zoom CT Scanners · Siemens Medical Solutions USA, Inc. · 1998K013522 · Somatom P30 CT Systems · Siemens Medical Systems, Inc. · 2001 · recalledK040665 · Somatom Sensation 64 and Sensation Cardiac · Siemens Medical Solutions USA, Inc. · 2004 · recalledK081022 · Somatom Definition, Model as/as+ · Siemens Medical Solutions USA, Inc. · 2008 · recalledK103127 · Somatom Definition as · Siemens Medical Solutions USA, Inc. · 2011 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 11 descendants3 generations forward: 6 descendants4 generations forward: 6 descendants5 generations forward: 5 descendants6 generations forward: 4 descendants7 generations forward: 5 descendants8 generations forward: 4 descendants9 generations forward: 2 descendants K103127 · Somatom Definition as · Siemens Medical Solutions USA, Inc. · 2011 · recalledK081022 · Somatom Definition, Model as/as+ · Siemens Medical Solutions USA, Inc. · 2008 · recalledK040665 · Somatom Sensation 64 and Sensation Cardiac · Siemens Medical Solutions USA, Inc. · 2004 · recalledK013522 · Somatom P30 CT Systems · Siemens Medical Systems, Inc. · 2001 · recalledK982349 · Somatom Plus 4WITH Volume Zoom CT Scanners · Siemens Medical Solutions USA, Inc. · 1998−50+5
  1. Root · 5 generations backK982349 Somatom Plus 4WITH Volume Zoom CT ScannersSiemens Medical Solutions USA, Inc. · 1998
  2. 4 generations backK013522 Somatom P30 CT SystemsSiemens Medical Systems, Inc. · 2001 · Recalled
  3. 3 generations backK040665 Somatom Sensation 64 and Sensation CardiacSiemens Medical Solutions USA, Inc. · 2004 · Recalled
  4. 2 generations backK081022 Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc. · 2008 · Recalled
  5. 1 generation backK103127 Somatom Definition asSiemens Medical Solutions USA, Inc. · 2011 · Recalled
  6. This deviceK130901 Somatom Definition as OpenSiemens Medical Systems, Inc. · 2014
  7. Descendant · cites it directly · 35 of its ownK143401 SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. · 2015 · Recalled
  8. Descendant · cites it directly · 32 of its ownK143400 SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · Recalled
  9. Descendant · 2 generations on · 28 of its ownK152036 SOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · Recalled
  10. Descendant · cites it directly · 27 of its ownK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
  11. Descendant · cites it directly · 25 of its ownK143416 SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc. · 2015 · Recalled

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2015: 82016: 62017: 52018: 42019: 42020: 32021: 22022: 22023: 42024: 32025: 62026: 2
2015high 8 (2015) · low 2 (2021)2026

Most influential descendants

Showing 5 of 49 · See all
  • K143401SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc. · 2015 · cites it directly35descendants
  • K143400SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · cites it directly32descendants
  • K152036SOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc. · 2015 · 2 generations on28descendants
  • K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc. · 2015 · cites it directly27descendants
  • K143416SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc. · 2015 · cites it directly25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K982349Somatom Plus 4WITH Volume Zoom CT ScannersSiemens Medical Solutions USA, Inc.1998—
−4K013522Somatom P30 CT SystemsSiemens Medical Systems, Inc.20019
−3K040665Somatom Sensation 64 and Sensation CardiacSiemens Medical Solutions USA, Inc.20045
−2K081022Somatom Definition, Model as/as+Siemens Medical Solutions USA, Inc.20083
−1K103127Somatom Definition asSiemens Medical Solutions USA, Inc.20116
0 (this device)K130901Somatom Definition as OpenSiemens Medical Systems, Inc.2014—
+1K143401SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc.20153
+1K143400SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc.20155
+2K152036SOMATOM Definition Edge, SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc.20154
+1K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM…Siemens Medical Solutions USA, Inc.201516
+1K143416SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc.20155

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201580
201660
201750
201840
201940
202030
202120
202220
202340
202430
202560
202620
FIG. 1 — Lineage of K130901, 1998–2026Source: 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K103127Somatom Definition as
Summary page 2
…Product Code: 90JAK Legally Marketed Predicate Device Trade Name: SOMATOM Definition AS Open 51 0(k)#: K1 03127 Clearance Date: March 04, 2011 Classification Name: Computed Tomography X-ray System Classificati…
Siemens Medical Solutions USA, Inc.20116
Kept off the family treeK2590321Siemens SOMATOM Definition Edge
Number could not be read

Also cleared against K103127: 1 other device →

What descends from it? (49)

See all 49

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

NumberDeviceApplicantDecidedDescendants
K143401SOMATOM Definition EdgeSiemens Medical Solutions USA, Inc.201535
K143400SOMATOM Definition AS/AS+Siemens Medical Solutions USA, Inc.201532
K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc.201527
K143416SOMATOM Definition Flash (VA48)Siemens Medical Solutions USA, Inc.201525
K143409SOMATOM Definition AS Open (VA48)Siemens Medical Solutions USA, Inc.201521
K142584iMARSiemens Medical Solutions USA, Inc.20150

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 16 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
  • 4 of the 6 ancestors have a recall of any class.
  • Of its descendants, K143401 (Siemens Medical Solutions USA, Inc., 2015) has gone furthest, with 35 descendants of its own.
  • 1 other device also cites its predicate K103127.

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. 2014, 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?

The Siemens SOMATOM Definition AS Open systems are 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 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.

Also cleared against K103127

1 other device cites the same predicate.

  • K172058CT6485, CT12885Analogic Corporation · 2018

More from Siemens Medical Systems, Inc.

25 FDA decisions under this applicant name. See the company

  • K133646AdmireSiemens 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
  • K122471Somatom DefinitionSiemens Medical Systems, Inc. · 20123 recalls

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/K130901 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130901: Somatom Definition as Open.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130901

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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