510(k) Report

510(k) · Cleared

Recalled · 2009

CT Perfusion 4

K052839510(k) TraditionalCleared Mar 10, 2006154-day reviewClass II21 CFR 892.1750Recalls 1

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

GE Healthcare · JAK System, X-Ray, Tomography, Computed

Cleared on Mar 10, 2006 as substantially equivalent to K010042 (General Electric Co., 2001) after a 154-day review. Its family tree reaches back 1 generation to 2001. 43 later devices descend from it. It has been recalled once.

Decided
Mar 10, 2006
Review
154 days
Class
Class II
Product code
JAK
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K010042 (2001). 43 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2008: 2 descendants cleared2020: 4 descendants cleared2007: 1 descendant cleared2015: 4 descendants cleared2009: 2 descendants cleared2013: 2 descendants cleared2012: 3 descendants cleared2025: 5 descendants cleared2018: 3 descendants cleared2017: 2 descendants cleared2016: 1 descendant cleared2014: 2 descendants cleared2022: 4 descendants cleared2019: 2 descendants cleared2021: 3 descendants cleared2024: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK010042 · CT Perfusion 2 · General Electric Co. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 7 descendants2 generations forward: 9 descendants3 generations forward: 9 descendants4 generations forward: 3 descendants5 generations forward: 3 descendants6 generations forward: 4 descendants7 generations forward: 3 descendants8 generations forward: 3 descendants9 generations forward: 2 descendants K010042 · CT Perfusion 2 · General Electric Co. · 20010+5
  1. Root · 1 generation backK010042 CT Perfusion 2General Electric Co. · 2001
  2. This deviceK052839 CT Perfusion 4GE Healthcare · 2006
  3. Descendant · cites it directly · 33 of its ownK073373 Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2007
  4. Descendant · cites it directly · 19 of its ownK073238 Syngo Volume Perfusion-CT NeuroSiemens AG Medical Solutions · 2008
  5. Descendant · 2 generations on · 13 of its ownK122909 Syngo Single Source Dual EngerySiemens Medical Systems, Inc. · 2012
  6. Descendant · 3 generations on · 12 of its ownK133677 Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2014
  7. Descendant · 4 generations on · 11 of its ownK150745 syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2015

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 22012: 32013: 22014: 22015: 42016: 12017: 22018: 32019: 22020: 42021: 32022: 42023: 12024: 12025: 52026: 1
2007high 5 (2025) · low 0 (2010)2026

Most influential descendants

Showing 5 of 43 · See all
  • K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions · 2007 · cites it directly33descendants
  • K073238Syngo Volume Perfusion-CT NeuroSiemens AG Medical Solutions · 2008 · cites it directly19descendants
  • K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc. · 2012 · 2 generations on13descendants
  • K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2014 · 3 generations on12descendants
  • K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc. · 2015 · 4 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K010042CT Perfusion 2General Electric Co.2001—
0 (this device)K052839CT Perfusion 4GE Healthcare2006—
+1K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions2007—
+1K073238Syngo Volume Perfusion-CT NeuroSiemens AG Medical Solutions2008—
+2K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.2012—
+3K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.2014—
+4K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200920
201230
201320
201420
201540
201610
201720
201830
201920
202040
202130
202240
202310
202410
202550
202610
FIG. 1 — Lineage of K052839, 2001–2026Source: 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? (1)

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
*K010042CT Perfusion 2
Summary page 1
…devices listed below: Model: CT Perfusion 2 Manufacturer: GE Medical Systems S.C.S, Buc, France 510(k) #: K010042 Device Description: CT Perfusion 4 is an image analysis software package that allows the evaluation of dynamic CT data followi…
General Electric Co.2001—

Also cleared against K010042: 4 other devices →

What descends from it? (43)

See all 43

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

NumberDeviceApplicantDecidedDescendants
K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733
K073238Syngo Volume Perfusion-CT NeuroSiemens AG Medical Solutions200819
K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910
K151212Ziostation2Qi Imaging, LLC20152
K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132
K193289FastStroke, CT Perfusion 4DGE Medical Systems SCS20201
K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080

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

Recalls of this device

DateClassRecallRoot causeReason
May 4, 2009Not classifiedZ-1720-2009Software designGE Healthcare has recently become aware of the need to adjust default settings associated with the use of CT Perfusion 4 on the Advantage Workstation, ST and PET/CT consoles that may impact patient safety. The default parameter settings…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K073373 (Siemens AG Medical Solutions, 2007) has gone furthest, with 33 descendants of its own.
  • 4 other devices also cite its predicate K010042.

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?

CT perfusion 4 is an image analysis software package that allows the user to produce dynamic image data and to generate information with regard to changes in image intensity over time. It supports the analysis of CT Perfusion images, obtained by cine imaging (in the head and body) after the intravenous injection of contrast, in calculation of the various perfusion-related parameters (i.e. regional blood flow, regional blood volume, mean transit time and…

Read the full statement (119 words)

CT perfusion 4 is an image analysis software package that allows the user to produce dynamic image data and to generate information with regard to changes in image intensity over time. It supports the analysis of CT Perfusion images, obtained by cine imaging (in the head and body) after the intravenous injection of contrast, in calculation of the various perfusion-related parameters (i.e. regional blood flow, regional blood volume, mean transit time and capillary permeability). The results are displayed in a user-friendly graphic format as parametric images.

This software will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability changes, which may be related to stroke or tumor angiogenesis and the treatment thereof.

Indications for use as stated in the FDA summary.

Also cleared against K010042

4 other devices cite the same predicate.

  • K050867Syngo Body Perfusion-CTSiemens AG · 2005
  • K043350Mistar, Model V3.2Apollo Medical Imaging Technology Pty., Ltd. · 2004
  • K033832Syngo Perfusion-CTSiemens AG Medical Solutions · 2003
  • K013214Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-001AToshiba America Medical Systems, In.C · 2001

More from GE Healthcare

223 FDA decisions under this applicant name. See the company

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The JAK category page

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https://510kreport.com/device/K052839 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052839: CT Perfusion 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052839

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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