510(k) Report

510(k) · Cleared

Recalled · 2005

Excelart with Pianissimo, Model MRT-1501/P3

K002531510(k) TraditionalCleared Oct 26, 200071-day reviewClass II21 CFR 892.1000Recalls 4

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

Toshiba America Mri, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Oct 26, 2000 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 76 later devices descend from it. It has been recalled 4 times.

Decided
Oct 26, 2000
Review
71 days
Class
Class II
Product code
LNH
Recalls
4
Predicates
0

76 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 2 descendants cleared2003: 1 descendant cleared2006: 2 descendants cleared2005: 1 descendant cleared2011: 6 descendants cleared2008: 2 descendants cleared2007: 1 descendant cleared2012: 6 descendants cleared2018: 7 descendants cleared2015: 4 descendants cleared2014: 1 descendant cleared2016: 2 descendants cleared2019: 4 descendants cleared2013: 1 descendant cleared2017: 3 descendants cleared2020: 7 descendants cleared2021: 9 descendants cleared2022: 5 descendants cleared2023: 2 descendants cleared2024: 5 descendants cleared2025: 3 descendants cleared2026: 2 descendants cleared200020052010201520202025
  1. This deviceK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000
  2. Descendant · cites it directly · 74 of its ownK023511 Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002 · Recalled
  3. Descendant · 2 generations on · 73 of its ownK032490 Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models…Toshiba America Medical Systems, In.C · 2003 · Recalled
  4. Descendant · 3 generations on · 69 of its ownK060003 Excelart Vantage ZGVToshibamedical Systems Corporation · 2006 · Recalled
  5. Descendant · 4 generations on · 68 of its ownK063361 Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · Recalled
  6. Descendant · 5 generations on · 61 of its ownK080038 Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008 · Recalled

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2002: 22003: 12005: 12006: 22007: 12008: 22011: 62012: 62013: 12014: 12015: 42016: 22017: 32018: 72019: 42020: 72021: 92022: 52023: 22024: 52025: 32026: 2
2002high 9 (2021) · low 0 (2004)2026

Most influential descendants

Showing 5 of 76 · See all
  • K023511Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002 · cites it directly74descendants
  • K032490Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and MRT-1503/P2Toshiba America Medical Systems, In.C · 2003 · 2 generations on73descendants
  • K060003Excelart Vantage ZGVToshibamedical Systems Corporation · 2006 · 3 generations on69descendants
  • K063361Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C · 2006 · 4 generations on68descendants
  • K080038Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C · 2008 · 5 generations on61descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002531Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc.2000—
+1K023511Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C20022
+2K032490Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and…Toshiba America Medical Systems, In.C20033
+3K060003Excelart Vantage ZGVToshibamedical Systems Corporation20061
+4K063361Excelart Vantage Atlas, Model MRT-1503Toshiba America Medical Systems, In.C20061
+5K080038Vantage Titan, Model MRT-1504/S3Toshiba America Medical Systems, In.C20082

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200310
200510
200620
200710
200820
201160
201260
201310
201410
201540
201620
201730
201870
201940
202070
202190
202250
202320
202450
202530
202620
FIG. 1 — Lineage of K002531, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (76)

See all 76

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

NumberDeviceApplicantDecidedDescendants
K023511Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C200274
K023207Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C20020

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

Recalls of this device

DateClassRecallRoot causeReason
May 25, 2005Not classifiedZ-0986-05OtherPatient information A is displayed with images for patient B.
Oct 6, 2004Not classifiedZ-0270-05OtherSoftware defect causes images to be rotated 180 degrees.
Jun 7, 2004Not classifiedZ-1045-04OtherWrong positioning may cause patient burns.
May 6, 2004Not classifiedZ-0937-04OtherSoftware anomaly.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K023511 (Toshiba America Medical Systems, In.C, 2002) has gone furthest, with 74 descendants of its own.

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

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

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

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
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

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

More from Toshiba America Mri, Inc.

68 FDA decisions under this applicant name. See the company

  • K002522Opart, Model MRT-600Toshiba America Mri, Inc. · 2000
  • K000549Opart, Model MRT-600Toshiba America Mri, Inc. · 2000
  • K993803Excelart with PianissimoToshiba America Mri, Inc. · 20003 recalls
  • K993574Opart/Prodiga, Opart/Protenza, Opart/ParagonToshiba America Mri, Inc. · 2000
  • K991740Opart, Model MRT-600Toshiba America Mri, Inc. · 1999

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https://510kreport.com/device/K002531 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002531: Excelart with Pianissimo, Model MRT-1501/P3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002531

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026