510(k) · Cleared

Recalled · 2004

Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2

K023511510(k) TraditionalCleared Nov 5, 200215-day reviewClass II21 CFR 892.1000Recalls 2

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

Toshiba America Medical Systems, In.C · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Nov 5, 2002 as substantially equivalent to K002531 (Toshiba America Mri, Inc., 2000) after a 15-day review. Its family tree reaches back 1 generation to 2000. 74 later devices descend from it. It has been recalled 2 times.

Decided: Nov 5, 2002
Review: 15 days
Class: Class II
Product code: LNH
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K002531 (2000). 74 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
This deviceK023511 Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002
Descendant · cites it directly · 73 of its ownK032490 Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models…Toshiba America Medical Systems, In.C · 2003 · Recalled
Descendant · 2 generations on · 69 of its ownK060003 Excelart Vantage ZGVToshibamedical Systems Corporation · 2006 · Recalled
Descendant · 3 generations on · 68 of its ownK063361 Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · Recalled
Descendant · 4 generations on · 61 of its ownK080038 Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008 · Recalled
Descendant · 5 generations on · 56 of its ownK102489 Vantage Titan 3TToshiba Medical Systems Corporation, Japan · 2011 · Recalled

Showing 5 of 74 descendants. See all descendants

Descendants cleared per year

2003high 9 (2021) · low 0 (2004)2026

Most influential descendants

Showing 5 of 74 · See all

K032490Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and MRT-1503/P2Toshiba America Medical Systems, In.C · 2003 · cites it directly73descendants
K060003Excelart Vantage ZGVToshibamedical Systems Corporation · 2006 · 2 generations on69descendants
K063361Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · 3 generations on68descendants
K080038Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008 · 4 generations on61descendants
K102489Vantage Titan 3TToshiba Medical Systems Corporation, Japan · 2011 · 5 generations on56descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002531	Excelart with Pianissimo, Model MRT-1501/P3	Toshiba America Mri, Inc.	2000	4
0 (this device)	K023511	Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2	Toshiba America Medical Systems, In.C	2002	—
+1	K032490	Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and…	Toshiba America Medical Systems, In.C	2003	3
+2	K060003	Excelart Vantage ZGV	Toshibamedical Systems Corporation	2006	1
+3	K063361	Excelart Vantage Atlas, Model MRT-1503	Toshiba America Medical Systems, In.C	2006	1
+4	K080038	Vantage Titan, Model MRT-1504/S3	Toshiba America Medical Systems, In.C	2008	2
+5	K102489	Vantage Titan 3T	Toshiba Medical Systems Corporation, Japan	2011	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2006	2	0
2007	1	0
2008	2	0
2011	6	0
2012	6	0
2013	1	0
2014	1	0
2015	4	0
2016	2	0
2017	3	0
2018	7	0
2019	4	0
2020	7	0
2021	9	0
2022	5	0
2023	2	0
2024	5	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K023511, 2000–2026Source: 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 LNH? 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 LNH device

#1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 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
*	K002531	Excelart with Pianissimo, Model MRT-1501/P3 Summary page 3 …1P3, MRT-l501/P2) Magnetic Resonance Imaging (MRI) system is substantially equivalent to the current EXCELARTTMwith Pianissimo XG/AG (model MRT-1501P3, MRT-I501/P2) (K002531) cleared on October 26,2000 except for new RF coils and dB/dt limitation. 1.4 ===…	Toshiba America Mri, Inc.	2000	4

Also cleared against K002531: 1 other device →

What descends from it? (74)

See all 74

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

Number	Device	Applicant	Decided	Descendants
K032490	Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and MRT-1503/P2	Toshiba America Medical Systems, In.C	2003	73

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 6, 2004	Not classified	Z-0270-05	Other	Software defect causes images to be rotated 180 degrees.
Jun 7, 2004	Not classified	Z-1045-04	Other	Wrong positioning may cause patient burns.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K032490 (Toshiba America Medical Systems, In.C, 2003) has gone furthest, with 73 descendants of its own.
1 other device also cites its predicate K002531.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007high 140 (2015) · low 35 (2007)2026

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

Recalls per year · LNH

8in 2025

2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, 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	12	35	25	114
2008	19	53	12	167
2009	17	70	7	194
2010	12	94	17	165
2011	16	81	11	182
2012	22	89	5	170
2013	19	108	2	107
2014	17	108	13	119
2015	19	140	12 (2)	113
2016	20	108	1	135
2017	18	98	0	121
2018	29	128	71	158
2019	26	62	5	158
2020	32	121	4	98
2021	27	87	41	84
2022	30	74	13	138
2023	30	124	10 (1)	159
2024	26	104	4	281
2025	26	122	8 (5)	1,263
2026	24	126	43	—

What is it indicated for?

Imaging of

The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck,

TMJ, heart, blood vessels). [Application terms include MRCP (MR

Cholangiopancreatography), MR Cisternography, MR Urography, MR Myelography, MR

Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac

tagging.] { KO0253 I }

Fluid Visualization { KO0253 1 }

2D / 3D Imaging { KO0253 1}

MR Angiography / MR Vascular Imaging (KO02531 }

BIood Oxygenation Level Dependent (BOLD) imaging (KO0253 1 }

Perfusion / Diffusion Imaging { K9938O3, KO0253 1 }

Proton Spectroscopy (K010129)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023511 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023511: Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023511

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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