510(k) · Cleared
Recalled · Class II · 2018Neuviz 64 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 16, 2012 as substantially equivalent to K040665 (Siemens Medical Solutions USA, Inc., 2004) and 1 other predicate after a 141-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Nov 16, 2012
- Review
- 141 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 3 generations to K982349 (1998). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK982349 Somatom Plus 4WITH Volume Zoom CT ScannersSiemens Medical Solutions USA, Inc. · 1998
- 2 generations backK013522 Somatom P30 CT SystemsSiemens Medical Systems, Inc. · 2001 · Recalled
- 1 generation backK040665 Somatom Sensation 64 and Sensation CardiacSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- This deviceK121792 Neuviz 64 Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK133373 ClearviewNeusoft Medical Systems Co., Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133373ClearviewNeusoft Medical Systems Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982349 | Somatom Plus 4WITH Volume Zoom CT Scanners | Siemens Medical Solutions USA, Inc. | 1998 | — |
| −2 | K013522 | Somatom P30 CT Systems | Siemens Medical Systems, Inc. | 2001 | 9 |
| −1 | K040665 | Somatom Sensation 64 and Sensation Cardiac | Siemens Medical Solutions USA, Inc. | 2004 | 5 |
| 0 (this device) | K121792 | Neuviz 64 Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2012 | — |
| +1 | K133373 | Clearview | Neusoft Medical Systems Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K040665 | Somatom Sensation 64 and Sensation CardiacSummary page 2…mage archive/evaluation. The NeuViz 64 Multi-slice CT Scanner System isof comparable type and substantially equivalent to the SIEMENS Sensation 64 CT system (K040665) and NeuViz 16 Multi-slice CT Scanner System(K092742). The NeuViz 64 system consists of two variants: - NeuViz 64i :… | 2004 |
| * | K092742 | Neuviz 16 Multi-Slice CT Scanner SystemSummary page 2…e CT Scanner System isof comparable type and substantially equivalent to the SIEMENS Sensation 64 CT system (K040665) and NeuViz 16 Multi-slice CT Scanner System(K092742). The NeuViz 64 system consists of two variants: - NeuViz 64i : Low configuration; - NeuViz 64e: High configuration.… | 2009 |
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 |
|---|---|---|---|
| K133373 | Clearview | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 22, 2018 | Class II | Z-1279-2019 | 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… |
| Aug 31, 2016 | Class II | Z-0876-2017 | Software design | The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error… |
| Aug 31, 2016 | Class II | Z-0875-2017 | Software design | The Firm discovered during contrast agent tracking scan, when the expected concentration of contrast agent is reached, later planned scan may be interrupted. The system must be powered down and restarted to clear the interruption error… |
| May 2, 2015 | Class II | Z-1650-2016 | Device Design | It was found by R&D in April, 2014 that there was a defect in NeuViz 64 system software version 1.0.5+P09. The icons of side decubitus didn't meet the patient position description, when the scanner position was set to "Right" in the… |
| Mar 8, 2014 | Class II | Z-1693-2015 | Radiation Control for Health and Safety Act | The A-plane compensator is made of Teflon which will become fragile due to X-ray exposure passing through it. The thinnest part of the compensator is subject to radiation degradation and as a result has been found to fail prematurely.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K133373 (Neusoft Medical Systems Co., Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K040665.
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. 2012, 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 64 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/K121792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121792: Neuviz 64 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/K121792
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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