510(k) Report

510(k) · Cleared

Recalled · 2005

Excelart with Pianissimo

K993803510(k) TraditionalCleared Feb 6, 200089-day reviewClass II21 CFR 892.1000Recalls 3

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 Feb 6, 2000 as substantially equivalent to K990620 (Toshiba America Mri, Inc., 1999) and 4 other predicates after an 89-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it. It has been recalled 3 times.

Decided
Feb 6, 2000
Review
89 days
Class
Class II
Product code
LNH
Recalls
3
Predicates
5

Its longest line of descent runs back 4 generations to K903768 (1990). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1992: 1 other ancestor2002: 1 descendant clearedReference device: K983110 · Flexart,Flexart/Hyper, Visart, Visart/Hyper · Toshiba America Mri, Inc. · 1999K903768 · Magnetic Resonance Device MRT 150A · Toshiba America Mri, Inc. · 1990K961092 · Visart · Toshiba America Medical Systems, In.C · 1996 · recalledK965068 · Magnetic Resonanc Dvce Visart V 3.5 Software · Toshiba America Medical Systems, In.C · 1997K990620 · Excelart · Toshiba America Mri, Inc. · 1999 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K990620 · Excelart · Toshiba America Mri, Inc. · 1999 · recalledK965068 · Magnetic Resonanc Dvce Visart V 3.5 Software · Toshiba America Medical Systems, In.C · 1997K961092 · Visart · Toshiba America Medical Systems, In.C · 1996 · recalledK903768 · Magnetic Resonance Device MRT 150A · Toshiba America Mri, Inc. · 19900
  1. Root · 4 generations backK903768 Magnetic Resonance Device MRT 150AToshiba America Mri, Inc. · 1990
  2. 3 generations backK961092 VisartToshiba America Medical Systems, In.C · 1996 · Recalled
  3. 2 generations backK965068 Magnetic Resonanc Dvce Visart V 3.5 SoftwareToshiba America Medical Systems, In.C · 1997
  4. 1 generation backK990620 ExcelartToshiba America Mri, Inc. · 1999 · Recalled
  5. This deviceK993803 Excelart with PianissimoToshiba America Mri, Inc. · 2000
  6. Descendant · cites it directly · 0 of its ownK023207 Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K023207Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K903768Magnetic Resonance Device MRT 150AToshiba America Mri, Inc.1990—
−3K961092VisartToshiba America Medical Systems, In.C19965
−2K965068Magnetic Resonanc Dvce Visart V 3.5 SoftwareToshiba America Medical Systems, In.C1997—
−1K990620ExcelartToshiba America Mri, Inc.19995
0 (this device)K993803Excelart with PianissimoToshiba America Mri, Inc.2000—
+1K023207Opart (Including Opart Ultra and Ultra Gradient Upgrade Kit)Toshiba America Medical Systems, In.C2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K993803, 1990–2002Source: 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), 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. #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
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What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K990620Excelart
Summary page 1
…MISSION: November 8, 1999 6. DEVICE DESCRIPTION: This submission consists of a new Magnetic Resonance Imaging system which is based primarily on the cleared EXCELART™ (K990620) with the following new functions added to the standard system. e Pianissimo: Gradient acoustic reduction system « QD Whole Bod…
Toshiba America Mri, Inc.19995
*K922798QD Whole Body Coil, MRT-150A
Summary page 2
…ally equivalent to existing cleared RF coils as compared in the following table: New caoil Substantially equivalent to: EXCELART™ QD Whole Body MRT-150A QD Whole Body {K922798) EXCELART™ C/T/L Spine Array | VISART QD Spine Array (K965068) EXCELART™ QD Head VISART QD Head (K961092) EXCELART™ Flex Body…
Toshiba America Mri, Inc.1992—
*K965068Magnetic Resonanc Dvce Visart V 3.5 Software
Summary page 2
…following table: New caoil Substantially equivalent to: EXCELART™ QD Whole Body MRT-150A QD Whole Body {K922798) EXCELART™ C/T/L Spine Array | VISART QD Spine Array (K965068) EXCELART™ QD Head VISART QD Head (K961092) EXCELART™ Flex Body VISART GP Flex (K965068) EXCELART™ Shoulder Array MRT-150A Sho…
Toshiba America Medical Systems, In.C1997—
*K961092Visart
Summary page 2
…quivalent to: EXCELART™ QD Whole Body MRT-150A QD Whole Body {K922798) EXCELART™ C/T/L Spine Array | VISART QD Spine Array (K965068) EXCELART™ QD Head VISART QD Head (K961092) EXCELART™ Flex Body VISART GP Flex (K965068) EXCELART™ Shoulder Array MRT-150A Shoulder (K942609) The optional software packa…
Toshiba America Medical Systems, In.C19965
*K942609MRT-150A Shoulder Coil
Summary page 2
…| VISART QD Spine Array (K965068) EXCELART™ QD Head VISART QD Head (K961092) EXCELART™ Flex Body VISART GP Flex (K965068) EXCELART™ Shoulder Array MRT-150A Shoulder (K942609) The optional software packages (EPI Plus, SuperFASE Plus, MRA Plus)} used for the EXCELART™ MRI system are based on the same so…
Toshiba America Mri, Inc.1994—
†K983110Flexart,Flexart/Hyper, Visart, Visart/HyperToshiba America Mri, Inc.1999—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
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.
May 6, 2004Not classifiedZ-0937-04OtherSoftware anomaly.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • Of its descendants, K023207 (Toshiba America Medical Systems, In.C, 2002) has gone furthest, with 0 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—

What is it indicated for?

Imaging of:

The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs and extremities). [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

Diffusion Imaging

The EPI Plus optional package adds the following to the above indications:

Perfusion Imaging

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Toshiba America Mri, Inc.

68 FDA decisions under this applicant name. See the company

  • K002531Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 20004 recalls
  • K002522Opart, Model MRT-600Toshiba America Mri, Inc. · 2000
  • K000549Opart, Model MRT-600Toshiba America Mri, Inc. · 2000
  • 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/K993803 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993803: Excelart with Pianissimo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993803

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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