510(k) · Cleared
ClearedSmartView 3D Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Hangwei Medical System Co., Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Mar 9, 2016 as substantially equivalent to K973168 (GE Medical Systems, 1997) after a 105-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Mar 9, 2016
- Review
- 105 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K940606 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK940606 Hispeed Advantage IIGE Medical Systems · 1994
- 2 generations backK964746 Hispeed CT/I with Performix Tube and Warp Scan OptionGE Medical Systems · 1997
- 1 generation backK973168 Smartview Options for Hispeed CT/IGE Medical Systems · 1997
- This deviceK153429 SmartView 3D OptionGe Hangwei Medical System Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940606 | Hispeed Advantage II | GE Medical Systems | 1994 | — |
| −2 | 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 | — |
| 0 (this device) | K153429 | SmartView 3D Option | Ge Hangwei Medical System Co., Ltd. | 2016 | — |
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 |
|---|---|---|---|
| * | K973168 | Smartview Options for Hispeed CT/ISummary page 4…uted Tomography X-ray System Classification Computed Tomography X-ray System 21CFR892.1750 Names: Regulatory Class Il Product Code: JAK Predicated SmartView Option (K973168) Device(s): Manufacturer(s): GE Hangwei Medical Systems Co., Ltd No. 1 North Yong Chang North Street Beijing Economy & Technol… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
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. 2016, 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?
The SmartView 3D option is used as part of a head or whole body CT interventional procedure when the physician desires to obtain a visualization, 3D orientation, and localization of the needle in patients of all ages. SmartView 3D can automatically detect various sized needles during CT interventional procedures. SmartView 3D reconstructs and displays the traditional 2D images, and immediately thereafter additionally displays Multiple Planar Reconstruction images from a reconstruction in an orthogonal reference frame aligned with the needle’s orientation where the needle tip is at the origin. This additional information may aid in guidance and/or monitoring during interventional procedures.
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/K153429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153429: SmartView 3D Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153429
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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