510(k) · Cleared
Recalled · 2008CT/E Computed Tomography Scannner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Dec 21, 1999 as substantially equivalent to K980169 (General Electric Co., 1998) after a 54-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 21, 1999
- Review
- 54 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980169 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK980169 Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of SystemsGeneral Electric Co. · 1998 · Recalled
- This deviceK993645 CT/E Computed Tomography Scannner SystemGe Medical Systems, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK021491 Hispeed DualGe Medical Systems, Inc. · 2002 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K021491Hispeed DualGe Medical Systems, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980169 | Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of Systems | General Electric Co. | 1998 | 2 |
| 0 (this device) | K993645 | CT/E Computed Tomography Scannner System | Ge Medical Systems, Inc. | 1999 | — |
| +1 | K021491 | Hispeed Dual | Ge Medical Systems, Inc. | 2002 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K980169 | Hispeed LX//I, Hispeed FX/I, and Hispeed DX/I Family of SystemsSummary page 1…ociated accessories. Materials: All construction and materials are compliant with 21 CFR Subchapter J and IEC 60601-1 and are equivalent to HiSpeed LX/i, FX/i and DX/i (K980169) Design: The system is designed to be a head and whole body CT scanner utilizing a solid state detector and an in… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021491 | Hispeed Dual | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2008 | Not classified | Z-2224-2009 | Radiation Control for Health and Safety Act | During internal testing, GE Healthcare has recently determined that the collimator used on our CT/e and HiSpeed X/i families of Computed Tomography systems does not comply with the specific requirements in United States Title 21 of the… |
| Oct 21, 2004 | Not classified | Z-0269-05 | Other | The patient tables of the affected CT systems are supported by a hydraulic cylinder and a cylinder shaft (i.e. the upper shaft) which connects the tabletop to the table frame. GE received a report of a HiSpeed LX/I system table falling… |
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?
The CT/e Computed Tomography system is intended for head and whole body x-ray computed tomography applications.
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/K993645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993645: CT/E Computed Tomography Scannner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993645
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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