510(k) · Cleared
ClearedHispeed CT/I with Performix Tube and Warp Scan Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · JAK System, X-Ray, Tomography, Computed
Cleared on Jan 24, 1997 as substantially equivalent to K940606 (GE Medical Systems, 1994) after a 59-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Jan 24, 1997
- Review
- 59 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940606 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK940606 Hispeed Advantage IIGE Medical Systems · 1994
- This deviceK964746 Hispeed CT/I with Performix Tube and Warp Scan OptionGE Medical Systems · 1997
- Descendant · cites it directly · 1 of its ownK973168 Smartview Options for Hispeed CT/IGE Medical Systems · 1997
- Descendant · 2 generations on · 0 of its ownK153429 SmartView 3D OptionGe Hangwei Medical System Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK012238 DoserightPhilips Medical Systems North America Co. · 2001
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940606 | Hispeed Advantage II | GE Medical Systems | 1994 | — |
| 0 (this device) | K964746 | Hispeed CT/I with Performix Tube and Warp Scan Option | GE Medical Systems | 1997 | — |
| +1 | K973168 | Smartview Options for Hispeed CT/I | GE Medical Systems | 1997 | — |
| +2 | K153429 | SmartView 3D Option | Ge Hangwei Medical System Co., Ltd. | 2016 | — |
| +1 | K012238 | Doseright | Philips Medical Systems North America Co. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K940606 | Hispeed Advantage IISummary page 1…iant with UL 187, IEC 601-1, and 21 CFR Subchapter | Design: The design of HiSpeed CT/i with Performix Tube and Warp Scan Option differs from the information covered in K940606 (HiSpeed CT/i) by the addition of the Performix tube which allows for the widening of mA specifications as well as the increased… | 1994 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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.
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?
HiSpeed CT/i with Performix Tube and Warp Scan Option is intended to provide 0.8 second 360-degree helical or axial scans as well as increase the maximum tube heat capacity and provides additional mA settings over our existing system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964746 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964746: Hispeed CT/I with Performix Tube and Warp Scan Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964746
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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