510(k) · Cleared

Recalled · Class II · 2008

Excelart Vantage Atlas, Model MRT-1503

K063361510(k) TraditionalCleared Nov 21, 200614-day reviewClass II21 CFR 892.1000Recalls 1

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 21, 2006 as substantially equivalent to K060003 (Toshibamedical Systems Corporation, 2006) after a 14-day review. Its family tree reaches back 4 generations to 2000. 68 later devices descend from it. It has been recalled once.

Decided: Nov 21, 2006
Review: 14 days
Class: Class II
Product code: LNH
Recalls: 1
Predicates: 1

Its longest line of descent runs back 4 generations to K002531 (2000). 68 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 4 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
3 generations backK023511 Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002 · Recalled
2 generations backK032490 Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models…Toshiba America Medical Systems, In.C · 2003 · Recalled
1 generation backK060003 Excelart Vantage ZGVToshibamedical Systems Corporation · 2006 · Recalled
This deviceK063361 Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006
Descendant · cites it directly · 61 of its ownK080038 Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008 · Recalled
Descendant · 2 generations on · 56 of its ownK102489 Vantage Titan 3TToshiba Medical Systems Corporation, Japan · 2011 · Recalled
Descendant · 3 generations on · 53 of its ownK113093 Vantage Titan 3TToshibamedical Systems Corporation · 2012 · Recalled
Descendant · 4 generations on · 52 of its ownK120487 Vantage Titan 3TToshibamedical Systems Corporation · 2012
Descendant · 5 generations on · 37 of its ownK132160 Vantage Titan 3TToshibamedical Systems Corporation · 2013

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2007high 9 (2021) · low 0 (2009)2026

Most influential descendants

Showing 5 of 68 · See all

K080038Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008 · cites it directly61descendants
K102489Vantage Titan 3TToshiba Medical Systems Corporation, Japan · 2011 · 2 generations on56descendants
K113093Vantage Titan 3TToshibamedical Systems Corporation · 2012 · 3 generations on53descendants
K120487Vantage Titan 3TToshibamedical Systems Corporation · 2012 · 4 generations on52descendants
K132160Vantage Titan 3TToshibamedical Systems Corporation · 2013 · 5 generations on37descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K002531	Excelart with Pianissimo, Model MRT-1501/P3	Toshiba America Mri, Inc.	2000	4
−3	K023511	Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2	Toshiba America Medical Systems, In.C	2002	2
−2	K032490	Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and…	Toshiba America Medical Systems, In.C	2003	3
−1	K060003	Excelart Vantage ZGV	Toshibamedical Systems Corporation	2006	1
0 (this device)	K063361	Excelart Vantage Atlas, Model MRT-1503	Toshiba America Medical Systems, In.C	2006	—
+1	K080038	Vantage Titan, Model MRT-1504/S3	Toshiba America Medical Systems, In.C	2008	2
+2	K102489	Vantage Titan 3T	Toshiba Medical Systems Corporation, Japan	2011	1
+3	K113093	Vantage Titan 3T	Toshibamedical Systems Corporation	2012	1
+4	K120487	Vantage Titan 3T	Toshibamedical Systems Corporation	2012	—
+5	K132160	Vantage Titan 3T	Toshibamedical Systems Corporation	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	2	0
2011	4	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 K063361, 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
*	K060003	Excelart Vantage ZGV Summary page 1 …1503/S3 * EXCELART Vantage Atlas-X Model No. MRT-1503/S3 The EXCELART Vantage Atlas MRI System is comparable to the EXCELART Vantage ZGV MRI System (K060003, cleared January 18, 2006) with the following modifications: · 16 Channel phased array system control * CPU perf…	Toshibamedical Systems Corporation	2006	1

Also cleared against K060003: 1 other device →

What descends from it? (68)

See all 68

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K080038	Vantage Titan, Model MRT-1504/S3	Toshiba America Medical Systems, In.C	2008	61
K111251	4CH Flex Speeder	Toshiba Medical Systems Coporation, Japan	2011	1
K083014	Atlas Speeder Head/Cervical Coil, Model Mjah-137A	Toshiba America Medical Systems, In.C	2008	1
K121911	Octave Speeder Spine	Toshiba Medical Systems Corporation, Japan	2012	0
K073081	Jet Software for Excelart Vantage Atlas-Z and Atlas-X	Toshiba America Medical Systems, In.C	2007	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 13, 2008	Class II	Z-2278-2012	Process design	The status display in the sequence queue window may not change from "Current" to "Done".

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
4 of the 4 ancestors have a recall of any class.
Of its descendants, K080038 (Toshiba America Medical Systems, In.C, 2008) has gone furthest, with 61 descendants of its own.
1 other device also cites its predicate K060003.

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.]

* Fluid Visualization

* 2D / 3D Imaging

* MR Angiography / MR Vascular Imaging

* Blood Oxygenation Level Dependent (BOLD) imaging

• Perfusion / Diffusion Imaging

* Proton Spectroscopy

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063361 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063361: Excelart Vantage Atlas, Model MRT-1503.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063361

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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