510(k) · Cleared
ClearedFastStroke
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gef Medical Systems Scs · JAK System, X-Ray, Tomography, Computed
Cleared on Jan 26, 2017 as substantially equivalent to K041521 (General Electric Medical Systems, 2004) after a 66-day review. Its family tree reaches back 3 generations to 1987. 2 later devices descend from it.
- Decided
- Jan 26, 2017
- Review
- 66 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K871859 (1987). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK871859 CT9800 Quick 3D #B7919DAGeneral Electric Co. · 1987
- 2 generations backK972399 Advantage Windows Volume Rendering OptionGe Medical Systems, Inc. · 1997 · Recalled
- 1 generation backK041521 Volume Viewer PlusGeneral Electric Medical Systems · 2004 · Recalled
- This deviceK163281 FastStrokeGef Medical Systems Scs · 2017
- Descendant · cites it directly · 1 of its ownK193289 FastStroke, CT Perfusion 4DGE Medical Systems SCS · 2020
- Descendant · 2 generations on · 0 of its ownK242624 Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871859 | CT9800 Quick 3D #B7919DA | General Electric Co. | 1987 | — |
| −2 | K972399 | Advantage Windows Volume Rendering Option | Ge Medical Systems, Inc. | 1997 | 1 |
| −1 | K041521 | Volume Viewer Plus | General Electric Medical Systems | 2004 | 2 |
| 0 (this device) | K163281 | FastStroke | Gef Medical Systems Scs | 2017 | — |
| +1 | K193289 | FastStroke, CT Perfusion 4D | GE Medical Systems SCS | 2020 | — |
| +2 | K242624 | Medical Image Post-processing Software (uOmnispace.CT) | Shanghai United Imaging Healthcare Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
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 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041521 | Volume Viewer PlusSummary page 4…ame: Computed Tomography X-ray System Classification Panel: Radiology Regulatory Class: Class II Product Code: JAK Predicate Device: K041521 - Volume Viewer Plus Regulation Number: 21CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regu… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193289 | FastStroke, CT Perfusion 4D | 2020 | 1 |
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 30 years and passes through 4 companies; a new generation was cleared every 10.1 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K193289 (GE Medical Systems SCS, 2020) has gone furthest, with 1 descendant of its own.
- 16 other devices also cite its predicate K041521.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for the purpose of displaying vasculature of the head and neck at different time points of enhancement. The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the…
Read the full statement (134 words)
FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for the purpose of displaying vasculature of the head and neck at different time points of enhancement.
The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the order of the scans and linking together multiple groups of scans. In addition, the software fuses the vascular information from different time points into a single colorized view. This multiphase information can aid the physician in visualizing the presence or absence of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163281 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163281: FastStroke.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163281
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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