510(k) Report

510(k) · Cleared

Cleared

Somatom Plus 4 CT Scanner

K964747510(k) TraditionalCleared Feb 10, 199776-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 Solutions USA, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Feb 10, 1997 as substantially equivalent to K941546 (Siemens Corp., 1994) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 1994. 265 later devices descend from it.

Decided
Feb 10, 1997
Review
76 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K940606 (1994). 2 ancestors in all. 265 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1998: 1 descendant cleared2001: 1 descendant cleared2004: 7 descendants cleared2008: 7 descendants cleared2003: 3 descendants cleared2009: 4 descendants cleared2017: 12 descendants cleared2011: 4 descendants cleared2007: 3 descendants cleared2005: 3 descendants cleared2016: 5 descendants cleared2006: 3 descendants cleared2015: 3 descendants cleared2018: 14 descendants cleared2019: 9 descendants cleared2014: 9 descendants cleared2013: 6 descendants cleared2010: 2 descendants cleared2012: 6 descendants cleared2020: 22 descendants cleared2024: 19 descendants cleared2023: 20 descendants cleared2025: 35 descendants cleared2022: 22 descendants cleared2021: 19 descendants cleared2026: 26 descendants clearedK940606 · Hispeed Advantage II · GE Medical Systems · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 11 descendants4 generations forward: 24 descendants5 generations forward: 43 descendants6 generations forward: 43 descendants7 generations forward: 29 descendants8 generations forward: 30 descendants9 generations forward: 26 descendants10 generations forward: 17 descendants11 generations forward: 13 descendants12 generations forward: 8 descendants13 generations forward: 10 descendants14 generations forward: 6 descendants15 generations forward: 2 descendants16 generations forward: 1 descendant K940606 · Hispeed Advantage II · GE Medical Systems · 19940+5+10+15
  1. Root · 1 generation backK940606 Hispeed Advantage IIGE Medical Systems · 1994
  2. This deviceK964747 Somatom Plus 4 CT ScannerSiemens Medical Solutions USA, Inc. · 1997
  3. Descendant · cites it directly · 264 of its ownK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
  4. Descendant · 2 generations on · 263 of its ownK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
  5. Descendant · 3 generations on · 214 of its ownK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
  6. Descendant · 3 generations on · 147 of its ownK042293 Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
  7. Descendant · 4 generations on · 92 of its ownK130159 Qlab Quantification Software Heart ModelPhilips Health Care · 2013

Showing 5 of 265 descendants. See all descendants

Descendants cleared per year

1998: 12001: 12003: 32004: 72005: 32006: 32007: 32008: 72009: 42010: 22011: 42012: 62013: 62014: 92015: 32016: 52017: 122018: 142019: 92020: 222021: 192022: 222023: 202024: 192025: 352026: 26
1998high 35 (2025) · low 0 (1999)2026

Most influential descendants

Showing 5 of 265 · See all
  • K982060Volumax CT Imaging SystemElscint, Inc. · 1998 · cites it directly264descendants
  • K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · 2 generations on263descendants
  • K033326Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · 3 generations on214descendants
  • K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc. · 2004 · 3 generations on147descendants
  • K130159Qlab Quantification Software Heart ModelPhilips Health Care · 2013 · 4 generations on92descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K940606Hispeed Advantage IIGE Medical Systems1994—
0 (this device)K964747Somatom Plus 4 CT ScannerSiemens Medical Solutions USA, Inc.1997—
+1K982060Volumax CT Imaging SystemElscint, Inc.1998—
+2K012009MX8000 Idt CT SystemMarconi Medical Systems, Inc.200161
+3K033326Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc.2003131
+3K042293Brilliance CT, Private Practice CV Configuration, CT ScannerPhilips Medical Systems (Cleveland), Inc.20041
+4K130159Qlab Quantification Software Heart ModelPhilips Health Care2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200110
200330
200470
200530
200630
200730
200870
200940
201020
201140
201260
201360
201490
201530
201650
2017120
2018140
201990
2020220
2021190
2022220
2023200
2024190
2025350
2026260
FIG. 1 — Lineage of K964747, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K941546Somatom Project 059
Summary page 2
…ubstantial Equivalence: The new SOMATOM Plus 4 CT Scanner is substantially equivalent to the following devices in commercial distribution: ¢ SOMATOM Plus 4 CT Scanner, K941546 Siemens Medical Systems, Inc. ' » HiSpeed Advantage, K940606 GE 5. Device Description: The SOMATOM Plus 4 with Somaris 4/B30 so…
Siemens Corp.1994—
*K940606Hispeed Advantage II
Summary page 2
…substantially equivalent to the following devices in commercial distribution: ¢ SOMATOM Plus 4 CT Scanner, K941546 Siemens Medical Systems, Inc. ' » HiSpeed Advantage, K940606 GE 5. Device Description: The SOMATOM Plus 4 with Somaris 4/B30 software is a whole body computed tomography X-ray scanner, wh…
GE Medical Systems1994—

Also cleared against K941546: 2 other devices →

What descends from it? (265)

See all 265

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

NumberDeviceApplicantDecidedDescendants
K982060Volumax CT Imaging SystemElscint, Inc.1998264

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K982060 (Elscint, Inc., 1998) has gone furthest, with 264 descendants of its own.
  • 2 other devices also cite its predicate K941546.

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 Plus 4 CT Scanner 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 angles or spiral planes* taken at different angles.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K941546

2 other devices cite the same predicate.

  • K991600Somatom Plus 4 with Sliding Gantry OptionSiemens Corp. · 1999
  • K982060Volumax CT Imaging SystemElscint, Inc. · 1998

More from Siemens Medical Solutions USA, Inc.

798 FDA decisions under this applicant name. See the company

  • K260055syngo.CT Brain QuantificationSiemens Medical Solutions USA, Inc. · 2026
  • K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc. · 2026
  • K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc. · 2026
  • P140011/S009MAMMOMAT B.brilliant with Tomosynthesis OptionSiemens Medical Solutions USA, Inc. · 2026
  • K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · 2026

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/K964747 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964747: Somatom Plus 4 CT Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964747

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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