510(k) · Cleared
Recalled · Class II · 2016Neuviz 16 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 Sep 22, 2009 after a 14-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 22, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 5
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK092742 Neuviz 16 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK121792 Neuviz 64 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK171198 NeuViz 16 Essence Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK133373 ClearviewNeusoft Medical Systems Co., Ltd. · 2014
Most influential descendants
Showing 3 of 3 · See all- K121792Neuviz 64 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2012 · cites it directly1descendant
- K171198NeuViz 16 Essence Multi-slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2017 · cites it directly0descendants
- K133373ClearviewNeusoft Medical Systems Co., Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092742 | Neuviz 16 Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2009 | — |
| +1 | K121792 | Neuviz 64 Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2012 | 5 |
| +1 | K171198 | NeuViz 16 Essence Multi-slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2017 | 1 |
| +2 | K133373 | Clearview | Neusoft Medical Systems Co., Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
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 |
|---|---|---|---|---|
| Mar 24, 2016 | Class II | Z-1573-2016 | Under Investigation by firm | The following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard used for copying and pasting images is not… |
| Mar 4, 2013 | Class II | Z-1165-2013 | Use error | User error of the NeuViz 16 or NeuViz Dual may cause personnel injuries. There was a report where a finger was pinched when the table was moved backward while the tabletop was controlled by another person from the gantry left control panel. |
| Oct 18, 2012 | Class II | Z-0466-2013 | Device Design | The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners. |
| Jun 8, 2012 | Class II | Z-2083-2012 | Device Design | One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz 16 CT scanner, which caused the Oil-accumulator to detach. |
| Feb 9, 2011 | Not classified | Z-2241-2011 | Other | Dimension measurement displays on a combined image were found inaccurate after the clinician merged multiple image series into one image. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K121792 (Neusoft Medical Systems Co., Ltd., 2012) has gone furthest, with 1 descendant 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. 2009, 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 16 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 with multislice capability up to 16 slices simultaneously. The acquired X-RAY'transmission data is reconstructed by computer into cross-sectional imagers of the body from the same axial plane taken at different angles. The system is suitable for all patients.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092742: Neuviz 16 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/K092742
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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