510(k) · Cleared
ClearedSmartview Options for Hispeed CT/I
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 Nov 21, 1997 as substantially equivalent to K940606 (GE Medical Systems, 1994) and 1 other predicate after an 88-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Nov 21, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K940606 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK940606 Hispeed Advantage IIGE Medical Systems · 1994
- 1 generation backK964746 Hispeed CT/I with Performix Tube and Warp Scan OptionGE Medical Systems · 1997
- This deviceK973168 Smartview Options for Hispeed CT/IGE Medical Systems · 1997
- Descendant · cites it directly · 0 of its ownK153429 SmartView 3D OptionGe Hangwei Medical System Co., Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K153429SmartView 3D OptionGe Hangwei Medical System Co., Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940606 | Hispeed Advantage II | GE Medical Systems | 1994 | — |
| −1 | K964746 | Hispeed CT/I with Performix Tube and Warp Scan Option | GE Medical Systems | 1997 | — |
| 0 (this device) | K973168 | Smartview Options for Hispeed CT/I | GE Medical Systems | 1997 | — |
| +1 | K153429 | SmartView 3D Option | Ge Hangwei Medical System Co., Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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…on are equivalent to the HiSpeed CT/i and are compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J. Design: The design is essentially the same as the HiSpeed CT/i (K940606) and CT/i with Performix Tube Option (K964746) the difference being that the SmartView option includes an in- room monitor, a han… | 1994 |
| * | K964746 | Hispeed CT/I with Performix Tube and Warp Scan OptionSummary page 1…compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J. Design: The design is essentially the same as the HiSpeed CT/i (K940606) and CT/i with Performix Tube Option (K964746) the difference being that the SmartView option includes an in- room monitor, a hand control, and a footswitch for initiating x-r… | 1997 |
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 |
|---|---|---|---|
| K153429 | SmartView 3D Option | 2016 | 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?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K153429 (Ge Hangwei Medical System Co., Ltd., 2016) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K940606.
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 SmartView Option for HiSpeed CT/i is indicated for head and whole body x-ray computed tomography applications.
The SmartView Option is a “real time” reconstruction with a display latency less than one second. An in-room monitor provides an image display with 6 frame/sec display of ninety, 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.
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/K973168 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973168: Smartview Options for Hispeed CT/I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973168
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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