510(k) · Cleared
Recalled · Class II · 2013Modification to Neuviz 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 Aug 16, 2007 as substantially equivalent to K062451 (Neusoft Medical Systems Co., Ltd., 2006) and 1 other predicate after a 99-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Aug 16, 2007
- Review
- 99 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 5 generations to K930090 (1993). 13 ancestors in all. 1 later device descends from it, 1 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 deviceK071308 Modification to Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK080540 Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0Neusoft Medical Systems Co., Ltd. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080540Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0Neusoft Medical Systems Co., Ltd. · 2008 · cites it directly0descendants
View 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) | K071308 | Modification to Neuviz Dual Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2007 | — |
| +1 | K080540 | Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0 | Neusoft Medical Systems Co., Ltd. | 2008 | — |
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 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K062451 | Neuviz Dual Multi-Slice CT Scanner SystemSummary page 3…taneously. The system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation. Predicated Device: K062451: NeuViz Dual Systems K033326: Philips Plus CT Scanner Statement of Substantial Equivalence: The NeuViz Dual (modified… | 2006 |
| * | K033326 | Philips Plus Computed Tomography SystemSummary page 3…an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation. Predicated Device: K062451: NeuViz Dual Systems K033326: Philips Plus CT Scanner Statement of Substantial Equivalence: The NeuViz Dual (modified) systems are of comparable type a… | 2003 |
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 |
|---|---|---|---|
| K080540 | Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0 | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 4, 2013 | Class II | Z-1166-2013 | 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. |
| 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 7 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 14 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K080540 (Neusoft Medical Systems Co., Ltd., 2008) has gone furthest, with 0 descendants 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. 2007, 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 Dual Systems (modified) 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/K071308 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071308: Modification to Neuviz Dual Multi-Slice CT Scanner System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071308
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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