510(k) · Cleared

Cleared

Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System

K151403510(k) TraditionalCleared Nov 2, 2015160-day reviewClass II21 CFR 892.1200

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

Neusoft Medical Systems Co., Ltd. · KPS System, Tomography, Computed, Emission

Cleared on Nov 2, 2015 as substantially equivalent to K050559 (GE Medical Systems, 2005) after a 160-day review. Its family tree reaches back 5 generations to 2001.

Decided: Nov 2, 2015
Review: 160 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K010641 (2001). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK010641 GE CT-Pet SystemGe Medical Systems, Inc. · 2001
4 generations backK023988 GE Discovery LS SystemGE Medical Systems · 2003 · Recalled
3 generations backK040172 Modification to GE Discovery LS SystemGE Medical Systems · 2004 · Recalled
2 generations backK041543 GE Discovery STGE Healthcare · 2004 · Recalled
1 generation backK050559 GE Discovery VCT SystemGE Medical Systems · 2005 · Recalled
This deviceK151403 Positron Emission Tomography (PET) and Computed Tomography (CT)…Neusoft Medical Systems Co., Ltd. · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K010641	GE CT-Pet System	Ge Medical Systems, Inc.	2001	—
−4	K023988	GE Discovery LS System	GE Medical Systems	2003	1
−3	K040172	Modification to GE Discovery LS System	GE Medical Systems	2004	5
−2	K041543	GE Discovery ST	GE Healthcare	2004	1
−1	K050559	GE Discovery VCT System	GE Medical Systems	2005	1
0 (this device)	K151403	Positron Emission Tomography (PET) and Computed Tomography (CT) System…	Neusoft Medical Systems Co., Ltd.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0

FIG. 1 — Lineage of K151403, 2001–2015Source: 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 KPS? 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 KPS device

#1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K050559	GE Discovery VCT System Summary page 5 …safety and effectiveness of these products could be ensured through verification, validation and difference assessment. Predicated Device: GE Discover VCT System(K050559) Reference Devices NeuViz 64 CT system (K121792). NSP-P8 PET Scanner(K090178) Statement of Substantial Equivalence: Th…	GE Medical Systems	2005	1
†	K133373	Clearview	Neusoft Medical Systems Co., Ltd.	2014	—
†	K121792	Neuviz 64 Multi-Slice CT Scanner System	Neusoft Medical Systems Co., Ltd.	2012	5
†	K090178	Attrius, Model PET150A6001, Attrius L, Model PET150A8001, Truesight, Model NSP-P6C…	Neusoft Positron Medical Systems Co., Ltd.	2009	—

Also cleared against K050559: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
5 of the 7 ancestors have a recall of any class.
2 other devices also cite its predicate K050559.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · KPS

12in 2025

2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007high 112 (2015) · low 25 (2008)2026

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

Recalls per year · KPS

16in 2025

2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007high 240 (2013) · low 10 (2016)2025

MAUDE reports naming product code KPS, 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	8	38	22	38
2008	17	25	16	11
2009	9	42	14	15
2010	3	91	4	44
2011	7	28	34	56
2012	6	94	13	34
2013	11	84	13	240
2014	11	92	18	33
2015	3	112	5	24
2016	11	65	16	10
2017	11	104	11	31
2018	13	59	12 (3)	26
2019	3	60	5 (5)	105
2020	12	72	8	22
2021	15	66	4	10
2022	5	60	8 (6)	15
2023	12	63	6 (3)	22
2024	11	59	15	23
2025	12	65	16	36
2026	6	67	6	—

What is it indicated for?

The NeuSight PET/CT Scanner System can be used for the functional and anatomical imaging of human bodies and organs. The device is intended for whole body or regional tumor examination, cardiac examination and head examination. The device can assist in radiotherapy planning and be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system. Trained doctors can read useful diagnostic information from the image generated.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K151403 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151403: Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151403

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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