510(k) Report

510(k) · Cleared

Cleared

Syngo Neuro Dsa CT

K053024510(k) TraditionalCleared Nov 4, 200514-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 AG · JAK System, X-Ray, Tomography, Computed

Cleared on Nov 4, 2005 as substantially equivalent to K043469 (Siemens AG Medical Solutions, 2005) and 1 other predicate after a 14-day review. Its family tree reaches back 5 generations to 1995. 8 later devices descend from it.

Decided
Nov 4, 2005
Review
14 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K954355 (1995). 10 ancestors in all. 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1998: 2 other ancestors2017: 1 descendant cleared2006: 1 descendant cleared2018: 1 descendant cleared2019: 1 descendant cleared2021: 2 descendants cleared2022: 2 descendants clearedK954355 · Advantage Windows 3D with Navigator Option · General Electric Co. · 1995K974715 · Advantage 3D XR · GE Medical Systems · 1998K984634 · 3D-Angio · Siemens Medical Corp. · 1999K011447 · IN Space 3D · Siemens Medical Solutions USA, Inc. · 2001K043469 · Syngo Inspace 4D · Siemens AG Medical Solutions · 20051995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 2 descendants6 generations forward: 1 descendant K043469 · Syngo Inspace 4D · Siemens AG Medical Solutions · 2005K011447 · IN Space 3D · Siemens Medical Solutions USA, Inc. · 2001K984634 · 3D-Angio · Siemens Medical Corp. · 1999K974715 · Advantage 3D XR · GE Medical Systems · 1998K954355 · Advantage Windows 3D with Navigator Option · General Electric Co. · 1995−50+5
  1. Root · 5 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
  2. 4 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
  3. 3 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
  4. 2 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
  5. 1 generation backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
  6. This deviceK053024 Syngo Neuro Dsa CTSiemens AG · 2005
  7. Descendant · cites it directly · 6 of its ownK163341 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2017
  8. Descendant · 2 generations on · 5 of its ownK173625 syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc. · 2018
  9. Descendant · 3 generations on · 4 of its ownK192402 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2019
  10. Descendant · 4 generations on · 3 of its ownK203699 syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc. · 2021
  11. Descendant · 5 generations on · 1 of its ownK214019 syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2022

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2006: 12017: 12018: 12019: 12021: 22022: 2
2006high 2 (2021) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · See all
  • K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2017 · cites it directly6descendants
  • K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on5descendants
  • K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2019 · 3 generations on4descendants
  • K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc. · 2021 · 4 generations on3descendants
  • K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2022 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K954355Advantage Windows 3D with Navigator OptionGeneral Electric Co.1995—
−4K974715Advantage 3D XRGE Medical Systems1998—
−3K9846343D-AngioSiemens Medical Corp.1999—
−2K011447IN Space 3DSiemens Medical Solutions USA, Inc.2001—
−1K043469Syngo Inspace 4DSiemens AG Medical Solutions2005—
0 (this device)K053024Syngo Neuro Dsa CTSiemens AG2005—
+1K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.2017—
+2K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.2018—
+3K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.2019—
+4K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.2021—
+5K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820
200010
200110
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201710
201810
201910
202120
202220
FIG. 1 — Lineage of K053024, 1995–2022Source: 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
*K043469Syngo Inspace 4D
Summary page 2
…software package: Manufacturer Product 51 0(k) Clearance date 1. Siemens InSpace 4D K043469 0210312005 2. Siemens Leonardo K040970 07/0812004 8. Device Descri…
Siemens AG Medical Solutions2005—
*K040970Leonardo
Summary page 2
…) Clearance date 1. Siemens InSpace 4D K043469 0210312005 2. Siemens Leonardo K040970 07/0812004 8. Device Description and Intended Use: syngo Neuro DSA CT is a dedicated post-processing appli…
Siemens Medical Systems, Inc.20041

Also cleared against K043469: 4 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176
K063507Syngo Neuro PBV CTSiemens AG20060

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 10 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
  • 3 of the 10 ancestors have a recall of any class.
  • Of its descendants, K163341 (Siemens Medical Solutions USA, Inc., 2017) has gone furthest, with 6 descendants of its own.
  • 4 other devices also cite its predicate K043469.

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?

syngo Neuro DSA CT is a dedicated post-processing application which allows removing bone structures from CT Angiography (CTA) data sets of the cerebral vasculature. Bone removal is based on a bone mask created from an additional non enhanced CT (NECT) scan that was three-dimensionally registered to the CTA data set.

Syngo Neuro DSA CT facilitates the diagnosis of the cerebral vasculature by removing interfering bone structures from CTA data. This particularly helps to delineate aneurysms and other vascular diseases in the area of the skull base.

Indications for use as stated in the FDA summary.

Also cleared against K043469

4 other devices cite the same predicate.

  • K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
  • K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
  • K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006
  • K062673Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006

More from Siemens AG

15 FDA decisions under this applicant name. See the company

  • K150843syngo®.via (version VB10A)Siemens AG · 2015
  • K123375Syngo.ViaSiemens AG · 20128 recalls
  • K110366Syngo.CT Cardiac FunctionSiemens AG · 20111 recall
  • K071310Syngo CT Oncology Software PackageSiemens AG · 2007
  • K063507Syngo Neuro PBV CTSiemens AG · 2006

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/K053024 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053024: Syngo Neuro Dsa CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053024

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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