510(k) · Cleared

Cleared

CT-C3000DUAL and CT-C2800DUAL Family of Dual-Slice CT Scanner Systems

K041542510(k) TraditionalCleared Jun 17, 20049-day reviewClass II21 CFR 892.1750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Neusoft Digital Medical Systems Co., Ltd. · JAK System, X-Ray, Tomography, Computed

Cleared on Jun 17, 2004 as substantially equivalent to K020913 (Neusoft Digital Medical Systems Co., Ltd., 2002) after a 9-day review. Its family tree reaches back 1 generation to 2002. 3 later devices descend from it.

Decided: Jun 17, 2004
Review: 9 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K020913 (2002). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK020913 CT-C3000 Spiral CT Scanner SystemNeusoft Digital Medical Systems Co., Ltd. · 2002
This deviceK041542 CT-C3000DUAL and CT-C2800DUAL Family of Dual-Slice CT Scanner SystemsNeusoft Digital Medical Systems Co., Ltd. · 2004
Descendant · cites it directly · 2 of its ownK062451 Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2006 · Recalled
Descendant · 2 generations on · 1 of its ownK071308 Modification to Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2007 · Recalled
Descendant · 3 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 3 of 3 · See all

K062451Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2006 · cites it directly2descendants
K071308Modification to Neuviz Dual Multi-Slice CT Scanner SystemNeusoft Medical Systems Co., Ltd. · 2007 · 2 generations on1descendant
K080540Neusoft Spiral CT Scanner System, Model Neuviz Version 2.0Neusoft Medical Systems Co., Ltd. · 2008 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K020913	CT-C3000 Spiral CT Scanner System	Neusoft Digital Medical Systems Co., Ltd.	2002	—
0 (this device)	K041542	CT-C3000DUAL and CT-C2800DUAL Family of Dual-Slice CT Scanner Systems	Neusoft Digital Medical Systems Co., Ltd.	2004	—
+1	K062451	Neuviz Dual Multi-Slice CT Scanner System	Neusoft Medical Systems Co., Ltd.	2006	6
+2	K071308	Modification to Neuviz Dual Multi-Slice CT Scanner System	Neusoft Medical Systems Co., Ltd.	2007	7
+3	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
2006	1	0
2007	1	0
2008	1	0

FIG. 1 — Lineage of K041542, 2002–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K020913	CT-C3000 Spiral CT Scanner System Summary page 2 …system software is an interactive program used for X-ray scan control, image reconstruction, and image archive/evaluation. Predicated Device: CT-C3000 system (K020913) Statement of Substantial Equivalence: The CT-C3000DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems are of…	Neusoft Digital Medical Systems Co., Ltd.	2002	—

Also cleared against K020913: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062451	Neuviz Dual Multi-Slice CT Scanner System	Neusoft Medical Systems Co., Ltd.	2006	2

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?

Its one ancestor has no recall.
Of its descendants, K062451 (Neusoft Medical Systems Co., Ltd., 2006) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K020913.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007high 543 (2018) · low 76 (2007)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 CT-C3000DUAL and CT-C2800DUAL Family of Dual-slice CT Scanner Systems 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/K041542 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041542: CT-C3000DUAL and CT-C2800DUAL Family of Dual-Slice CT Scanner Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041542

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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