510(k) · Cleared
Recalled · Class II · 2012Neuviz Dual 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 28, 2006 as substantially equivalent to K041542 (Neusoft Digital Medical Systems Co., Ltd., 2004) after a 37-day review. Its family tree reaches back 2 generations to 2002. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- Sep 28, 2006
- Review
- 37 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020913 (2002). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK020913 CT-C3000 Spiral CT Scanner SystemNeusoft Digital Medical Systems Co., Ltd. · 2002
- 1 generation backK041542 CT-C3000DUAL and CT-C2800DUAL Family of Dual-Slice CT Scanner SystemsNeusoft Digital Medical Systems Co., Ltd. · 2004
- This deviceK062451 Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2006
- Descendant · cites it directly · 1 of its ownK071308 Modification to Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK080540 Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0Neusoft Medical Systems Co., Ltd. · 2008
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 |
|---|---|---|---|---|---|
| −2 | K020913 | CT-C3000 Spiral CT Scanner System | Neusoft Digital Medical Systems Co., Ltd. | 2002 | — |
| −1 | K041542 | CT-C3000DUAL and CT-C2800DUAL Family of Dual-Slice CT Scanner Systems | Neusoft Digital Medical Systems Co., Ltd. | 2004 | — |
| 0 (this device) | K062451 | Neuviz Dual Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2006 | — |
| +1 | K071308 | Modification to Neuviz Dual Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2007 | 7 |
| +2 | K080540 | Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0 | Neusoft Medical Systems Co., Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K041542 | CT-C3000DUAL and CT-C2800DUAL Family of Dual-Slice CT Scanner SystemsSummary page 2…ray scan control, image reconstruction, and image archive/evaluation. Predicated Device: CT-C3000DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems (K041542) Statement of Substantial Equivalence: The NeuViz Dual systems are of comparable type and substantially equivalent to the… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071308 | Modification to Neuviz Dual Multi-Slice CT Scanner System | 2007 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
| Feb 10, 2010 | Not classified | Z-0846-2011 | Other | Potential for the CT patient table top to become detached from the carrier due to missing washers. |
| Jul 21, 2008 | Not classified | Z-2237-2010 | Software design | The reference lines for image generated for a Surview scan may appear in the incorrect position in the "FILM" display mode. |
| Jun 23, 2008 | Not classified | Z-2307-2008 | Nonconforming Material/Component | Potential for R-host box and components inside to be detached of its mounting during the gantry rotor rotation. There is a potential for components to be damaged inside the system gantry and for the internal components to be expelled from… |
| Apr 10, 2008 | Not classified | Z-0001-2009 | Software design | An issue associated with the "Timed Scan" application was found. The system does not wait for the programmed time interval and starts the x-ray after selection of the scan button when certain criteria is met. |
| Dec 17, 2007 | Not classified | Z-2235-2008 | Software design | Labeling of patient position on scanned image does not match actual patient orientation. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K071308 (Neusoft Medical Systems Co., Ltd., 2007) 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.
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 Dual Multi-slice CT Scanner System -NeuViz Dual (H)and NeuViz Dual (L) - are intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062451: Neuviz Dual 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/K062451
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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