510(k) Report

510(k) · Cleared

Cleared

QD Knee/Foot Coil, Model MJQJ-147A

K051763510(k) TraditionalCleared Jul 14, 200514-day reviewClass II21 CFR 892.1000

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 · MOS Coil, Magnetic Resonance, Specialty

Cleared on Jul 14, 2005 as substantially equivalent to K032490 (Toshiba America Medical Systems, In.C, 2003) after a 14-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.

Decided
Jul 14, 2005
Review
14 days
Class
Class II
Product code
MOS
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K002531 (2000). 2 later devices descend from it, 1 citing it directly.

  1. Root · 3 generations backK002531 Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc. · 2000 · Recalled
  2. 2 generations backK023511 Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C · 2002 · Recalled
  3. 1 generation backK032490 Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models…Toshiba America Medical Systems, In.C · 2003 · Recalled
  4. This deviceK051763 QD Knee/Foot Coil, Model MJQJ-147AToshiba America Medical Systems, In.C · 2005
  5. Descendant · cites it directly · 1 of its ownK103185 Toshiba 1.5T Extra Large Knee CoilQuality Electrodynamics · 2011
  6. Descendant · 2 generations on · 0 of its ownK112313 Toshiba 3T Extra Large Knee CoilQuality Electrodynamics · 2011

Most influential descendants

Showing 2 of 2 · See all
  • K103185Toshiba 1.5T Extra Large Knee CoilQuality Electrodynamics · 2011 · cites it directly1descendant
  • K112313Toshiba 3T Extra Large Knee CoilQuality Electrodynamics · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K002531Excelart with Pianissimo, Model MRT-1501/P3Toshiba America Mri, Inc.20004
−2K023511Excelart with Pianissimo XG/AG Spin Edition, Model MRT-1501/P3, P2Toshiba America Medical Systems, In.C20022
−1K032490Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and…Toshiba America Medical Systems, In.C20033
0 (this device)K051763QD Knee/Foot Coil, Model MJQJ-147AToshiba America Medical Systems, In.C2005—
+1K103185Toshiba 1.5T Extra Large Knee CoilQuality Electrodynamics2011—
+2K112313Toshiba 3T Extra Large Knee CoilQuality Electrodynamics2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201120
FIG. 1 — Lineage of K051763, 2000–2011Source: 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 MOS? 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 MOS device

  1. #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K032490Toshiba Excelart Vantage XGV/Agv Mri Diagnostic System, Models MRT-1503/P3 and MRT-1503/P2
Summary page 2
…VALENCY INFORMATION Toshiba Medical Systems Corporation believes that this 0D Knee/Foot coil is substantially equivalent to the current OD Knee coil (K032490). A-3 t DEPARTMENT OF HEALTH & HUMAN SERVICES…
Toshiba America Medical Systems, In.C20033

Also cleared against K032490: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K103185Toshiba 1.5T Extra Large Knee CoilQuality Electrodynamics20111

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 5 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
  • 3 of the 3 ancestors have a recall of any class.
  • Of its descendants, K103185 (Quality Electrodynamics, 2011) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K032490.

How does its category compare?

All MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOS

3in 2025

2007: 162008: 192009: 102010: 162011: 252012: 152013: 72014: 122015: 62016: 112017: 92018: 102019: 32020: 52021: 42022: 112023: 102024: 102025: 32026 (partial year): 10
2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007: 19 days median2008: 33 days median2009: 43 days median2010: 78 days median2011: 57 days median2012: 49 days median2013: 87 days median2014: 60 days median2015: 58 days median2016: 42 days median2017: 63 days median2018: 30 days median2019: 178 days median2020: 51 days median2021: 41 days median2022: 79 days median2023: 59 days median2024: 39 days median2025: 59 days median2026 (partial year): 45 days median
2007high 178 (2019) · low 19 (2007)2026

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

Recalls per year · MOS

13in 2024

2008: 22010: 12012: 12015: 22019: 82020: 12024: 13
2007high 13 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MOS

2in 2025

2007: 42008: 22009: 52010: 132011: 72012: 122013: 102014: 42015: 52016: 72017: 92018: 72019: 82020: 22021: 32022: 52023: 42024: 82025: 2
2007high 13 (2010) · low 2 (2008)2025

MAUDE reports naming product code MOS, 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
2007161904
2008193322
2009104305
20101678113
2011255707
20121549112
2013787010
2014126004
201565825
2016114207
201796309
2018103007
2019317888
202055112
202144103
2022117905
2023105904
20241039138
202535902
202610450—

What is it indicated for?

Imaging of:

• Diagnostic imaging of the knee, ankle and foot regions

• Fluid visualization

• 2D and 3D imaging

• MR angiography

• MR fluoroscopy

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K051763: QD Knee/Foot Coil, Model MJQJ-147A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051763

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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