510(k) · Cleared
ClearedComputed Tomography X-Ray System
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 Apr 4, 1997 after a 45-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Apr 4, 1997
- Review
- 45 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK970606 Computed Tomography X-Ray SystemGE Medical Systems · 1997
- Descendant · cites it directly · 0 of its ownK974344 CT ScopeElscint, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K974344CT ScopeElscint, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970606 | Computed Tomography X-Ray System | GE Medical Systems | 1997 | — |
| +1 | K974344 | CT Scope | Elscint, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K974344 | CT Scope | 1998 | 0 |
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?
- Of its descendants, K974344 (Elscint, Inc., 1998) has gone furthest, with 0 descendants of its own.
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 ProSpeed Family of CT Systems with ProSpeed Renaissance Options is indicated for head and whole body x-ray computed tomography applications. These options are modifications which can be added to the existing family of ProSpeed Systems. The options include Warp Scan Option which is intended to provide 0.8 second 360-degree helical or axial scans. Fluoro Scan Option is an almost “real time” reconstruction (Smart Recon) with a display latency of 0.8…
Read the full statement (198 words)
The CT ProSpeed Family of CT Systems with ProSpeed Renaissance Options is indicated for head and whole body x-ray computed tomography applications. These options are modifications which can be added to the existing family of ProSpeed Systems. The options include Warp Scan Option which is intended to provide 0.8 second 360-degree helical or axial scans.
Fluoro Scan Option is an almost “real time” reconstruction (Smart Recon) with a display latency of 0.8 to 1.6 seconds. An in-room monitor provides an image display with either a 3 frame/ sec or 6 frame/sec display of 90 one second rotation scans. Controls are provided for the control of the table and gantry by a physician or their assistant during procedures that require imaging.
SmartPrep Option is a tool to aid in triggering a helical or axial series of scans after contrast is injected. It allows the operator to monitor contrast as it enhances. A series of images, acquired immediately after injection, is automatically displayed along with pre-selected regions of interest. A graph plots the increase in CT numbers. When the region of interest begins approaching peak enhancement the operator can see that happen on the graph and initiate the CT series.
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/K970606 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970606: Computed Tomography X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970606
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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