510(k) Report

510(k) · Cleared

Cleared

Syngo Neuro PBV CT

K063507510(k) TraditionalCleared Nov 30, 200610-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 30, 2006 as substantially equivalent to K053024 (Siemens AG, 2005) and 2 other predicates after a 10-day review. Its family tree reaches back 6 generations to 1995.

Decided
Nov 30, 2006
Review
10 days
Class
Class II
Product code
JAK
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K954355 (1995). 17 ancestors in all, the oldest K880965 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor2003: 1 other ancestor2001: 2 other ancestors1998: 3 other ancestors1991: 1 other ancestor1988: 2 other ancestors2000: 1 other ancestorK954355 · 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 · 2005K053024 · Syngo Neuro Dsa CT · Siemens AG · 200519851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors4 generations back: 2 other ancestors5 generations back: 1 other ancestor K053024 · Syngo Neuro Dsa CT · Siemens AG · 2005K043469 · 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
  1. Root · 6 generations backK954355 Advantage Windows 3D with Navigator OptionGeneral Electric Co. · 1995
  2. 5 generations backK974715 Advantage 3D XRGE Medical Systems · 1998
  3. 4 generations backK984634 3D-AngioSiemens Medical Corp. · 1999
  4. 3 generations backK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
  5. 2 generations backK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
  6. 1 generation backK053024 Syngo Neuro Dsa CTSiemens AG · 2005
  7. This deviceK063507 Syngo Neuro PBV CTSiemens AG · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K954355Advantage Windows 3D with Navigator OptionGeneral Electric Co.1995—
−5K974715Advantage 3D XRGE Medical Systems1998—
−4K9846343D-AngioSiemens Medical Corp.1999—
−3K011447IN Space 3DSiemens Medical Solutions USA, Inc.2001—
−2K043469Syngo Inspace 4DSiemens AG Medical Solutions2005—
−1K053024Syngo Neuro Dsa CTSiemens AG2005—
0 (this device)K063507Syngo Neuro PBV CTSiemens AG2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198820
199110
199830
200010
200120
200310
200410
FIG. 1 — Lineage of K063507, 1995–2006Source: 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
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What was it cleared against? (3)

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
*K053024Syngo Neuro Dsa CT
Summary page 2
…device: Manufacturer Product 510(k) Clearance date 1. Siemens NeuroDSA CT K053024 11/04/2005 /*16ko 2. Siemens Perfusion CT K033832 12/23/2003 3. Siemen…
Siemens AG2005—
*K033832Syngo Perfusion-CT
Summary page 2
…e date 1. Siemens NeuroDSA CT K053024 11/04/2005 /*16ko 2. Siemens Perfusion CT K033832 12/23/2003 3. Siemens AG Leonardo (syngo Fused Vision 3D) K040970 07/08/2004 8. Device Descri…
Siemens AG Medical Solutions2003—
*K040970Leonardo
Summary page 2
…4/2005 /*16ko 2. Siemens Perfusion CT K033832 12/23/2003 3. Siemens AG Leonardo (syngo Fused Vision 3D) K040970 07/08/2004 8. Device Description and Intended Use: syngo Neuro PBV CT is a dedicated post-processing applicati…
Siemens Medical Systems, Inc.20041

Also cleared against K053024: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 11 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
  • 3 of the 17 ancestors have a recall of any class.
  • 1 other device also cites its predicate K053024.

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 PBV CT is a dedicated post-processing application used in cases of suspected stroke. The application calculates a volume that represents the amount of blood in the parenchyma. Decreased blood volume in a certain region of the brain is an indicator for stroke. As syngo Neuro PBV CT calculates a blood volume the stroke region can be measured in 3D. Neuro PBV CT is calculated using a non-enhanced CT dataset (NECT) and a CT Angiography (CTA) that…

Read the full statement (161 words)

syngo Neuro PBV CT is a dedicated post-processing application used in cases of suspected stroke. The application calculates a volume that represents the amount of blood in the parenchyma. Decreased blood volume in a certain region of the brain is an indicator for stroke. As syngo Neuro PBV CT calculates a blood volume the stroke region can be measured in 3D.

Neuro PBV CT is calculated using a non-enhanced CT dataset (NECT) and a CT Angiography (CTA) that both are acquired during modern stroke protocol. The two volumes are first registered and after segmentation of bones, CSF, and vessels the volumes are low pass filtered and subtracted. The result is adjusted to the enhancement of a vessel to allow semi-quantitative measurements.

Syngo Neuro PBV CT helps to diagnosing stroke while enlarging the cerebral blood volume (CBV) of perfusion CT (PCT) that covers only a portion of the brain. Thus it facilitates the treatment decision and is an addition to Perfusion CT.

Indications for use as stated in the FDA summary.

Also cleared against K053024

1 other device cites the same predicate.

  • K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc. · 2017

More from Siemens AG

15 FDA decisions under this applicant name. See the company

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  • K110366Syngo.CT Cardiac FunctionSiemens AG · 20111 recall
  • K071310Syngo CT Oncology Software PackageSiemens AG · 2007
  • K063373Flex Loop Coil Set 3TSiemens AG · 2006

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https://510kreport.com/device/K063507 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063507: Syngo Neuro PBV CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063507

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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