510(k) · Cleared
ClearedCT-C3000 Spiral CT Scanner System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neusoft Digital Medical Systems Co., Ltd. · JAK System, X-Ray, Tomography, Computed
Cleared on Apr 3, 2002 after a 13-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Apr 3, 2002
- Review
- 13 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK020913 CT-C3000 Spiral CT Scanner SystemNeusoft Digital Medical Systems Co., Ltd. · 2002
- Descendant · cites it directly · 3 of its ownK041542 CT-C3000DUAL and CT-C2800DUAL Family of Dual-Slice CT Scanner SystemsNeusoft Digital Medical Systems Co., Ltd. · 2004
- Descendant · 2 generations on · 2 of its ownK062451 Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2006 · Recalled
- Descendant · 3 generations on · 1 of its ownK071308 Modification to Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2007 · Recalled
- Descendant · 4 generations on · 0 of its ownK080540 Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0Neusoft Medical Systems Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK072841 Neuviz Spiral CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2007
Most influential descendants
Showing 5 of 5 · See all- K041542CT-C3000DUAL and CT-C2800DUAL Family of Dual-Slice CT Scanner SystemsNeusoft Digital Medical Systems Co., Ltd. · 2004 · cites it directly3descendants
- K062451Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2006 · 2 generations on2descendants
- K071308Modification to Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2007 · 3 generations on1descendant
- K080540Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0Neusoft Medical Systems Co., Ltd. · 2008 · 4 generations on0descendants
- K072841Neuviz Spiral CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K062451 | Neuviz Dual Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2006 | 6 |
| +3 | K071308 | Modification to Neuviz Dual Multi-Slice CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2007 | 7 |
| +4 | K080540 | Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0 | Neusoft Medical Systems Co., Ltd. | 2008 | — |
| +1 | K072841 | Neuviz Spiral CT Scanner System | Neusoft Medical Systems Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041542 (Neusoft Digital Medical Systems Co., Ltd., 2004) has gone furthest, with 3 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.
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?
CT-C3000 System is intended to produce cross-section images of head and whole body by computer reconstruction of X-ray transmission data taken at different angles.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020913: CT-C3000 Spiral 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/K020913
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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