510(k) · Cleared
Recalled · Class II · 2019NeuViz 128 Multi-slice CT Scanner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neusoft Medical Systems Co., Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 4, 2015 as substantially equivalent to K033326 (Philips Medical Systems, Inc., 2003) after a 166-day review. Its family tree reaches back 5 generations to 1993. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 4, 2015
- Review
- 166 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930090 (1993). 10 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK930090 HelicatElscint, Inc. · 1993
- 4 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 3 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 2 generations backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK033326 Philips Plus Computed Tomography SystemPhilips Medical Systems, Inc. · 2003 · Recalled
- This deviceK151383 NeuViz 128 Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK230220 NeuViz 128 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK171201 NeuViz Prime Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −4 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −3 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −2 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| −1 | K033326 | Philips Plus Computed Tomography System | Philips Medical Systems, Inc. | 2003 | 131 |
| 0 (this device) | K151383 | NeuViz 128 Multi-slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2015 | — |
| +1 | K230220 | NeuViz 128 Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2023 | — |
| +1 | K171201 | NeuViz Prime Multi-slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K033326 | Philips Plus Computed Tomography SystemSummary page 6…diac Function Analysis z Cardiac Viewer z Fat Analysis z CTDSA z Tumor Assessment Predicated Device: Philips Ingenuity Core128 CT System(K033326) Reference Device NeuViz 64e CT system (K121792). Statement of Substantial Equivalence: The NeuViz 128 Multi-slice CT Sc… | 2003 |
| † | K121792 | Neuviz 64 Multi-Slice CT Scanner System | 2012 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 9, 2019 | Class II | Z-0773-2019 | Software design | For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). When user plans and performs subsequent clinical scan with the wrong FOV the actual start and… |
| Oct 22, 2018 | Class II | Z-1280-2019 | Software design | Software defect: For Helical scan with ClearView function, when small arc (uninterrupted scan) occurs during scan, there will be some electromagnetic interference in the system which may affect the control signal of the flying focal spot… |
| May 19, 2017 | Class II | Z-3045-2017 | Software design | Software defect |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 10 ancestors have a recall of any class.
- Of its descendants, K230220 (Neusoft Medical Systems Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K033326.
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. 2015, 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 NeuViz 128 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151383: NeuViz 128 Multi-slice CT Scanner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151383
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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