510(k) Report

510(k) · Cleared

Cleared

Excalibur 9000 Totalsense Quad Head Array Coil

K022582510(k) TraditionalCleared Oct 22, 200278-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

Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Oct 22, 2002 as substantially equivalent to K001870 (Usa Instruments, Inc., 2000) and 1 other predicate after a 78-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it.

Decided
Oct 22, 2002
Review
78 days
Class
Class II
Product code
MOS
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K964531 (1997). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2004: 1 descendant cleared2008: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared2012: 1 descendant cleared2015: 1 descendant clearedK964531 · Profile 70000 Quadrature Volume Neck Coil · Us Asia Instruments, Inc. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 1 descendant K964531 · Profile 70000 Quadrature Volume Neck Coil · Us Asia Instruments, Inc. · 19970
  1. Root · 1 generation backK964531 Profile 70000 Quadrature Volume Neck CoilUs Asia Instruments, Inc. · 1997
  2. This deviceK022582 Excalibur 9000 Totalsense Quad Head Array CoilUsa Instruments, Inc. · 2002
  3. Descendant · cites it directly · 5 of its ownK041487 QD Head Speeder with Speeder NV AttachmentUsa Instruments, Inc. · 2004
  4. Descendant · 2 generations on · 4 of its ownK083160 1.5T Atlas Speeder Head-Neck CoilQuality Electrodynamics · 2008 · Recalled
  5. Descendant · 3 generations on · 1 of its ownK142802 Atlas SPEEDER Head/NeckQuality Electrodynamics, LLC · 2014
  6. Descendant · 4 generations on · 0 of its ownK151829 Atlas SPEEDER Header/NeckQuality Electrodynamics, LLC · 2015
  7. Descendant · 3 generations on · 0 of its ownK122638 Toshiba 3T 32CH Head Speeder Coil,Quality Electrodynamics · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2004: 12008: 12010: 12012: 12014: 12015: 1
2004high 1 (2004) · low 0 (2005)2026

Most influential descendants

Showing 5 of 6 · See all
  • K041487QD Head Speeder with Speeder NV AttachmentUsa Instruments, Inc. · 2004 · cites it directly5descendants
  • K0831601.5T Atlas Speeder Head-Neck CoilQuality Electrodynamics · 2008 · 2 generations on4descendants
  • K142802Atlas SPEEDER Head/NeckQuality Electrodynamics, LLC · 2014 · 3 generations on1descendant
  • K151829Atlas SPEEDER Header/NeckQuality Electrodynamics, LLC · 2015 · 4 generations on0descendants
  • K122638Toshiba 3T 32CH Head Speeder Coil,Quality Electrodynamics · 2012 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K964531Profile 70000 Quadrature Volume Neck CoilUs Asia Instruments, Inc.1997—
0 (this device)K022582Excalibur 9000 Totalsense Quad Head Array CoilUsa Instruments, Inc.2002—
+1K041487QD Head Speeder with Speeder NV AttachmentUsa Instruments, Inc.2004—
+2K0831601.5T Atlas Speeder Head-Neck CoilQuality Electrodynamics20081
+3K142802Atlas SPEEDER Head/NeckQuality Electrodynamics, LLC2014—
+4K151829Atlas SPEEDER Header/NeckQuality Electrodynamics, LLC2015—
+3K122638Toshiba 3T 32CH Head Speeder Coil,Quality Electrodynamics2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200810
201010
201210
201410
201510
FIG. 1 — Lineage of K022582, 1997–2015Source: 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K001870Millennium 9000 Phased Array Neurovascular Coil
Summary page 2
…he Millennium 9000 Phased Array Decoupling isolates the coil elements Neurovascular Coil manufactured by USA from RF fields during RF transmission; Instruments, Inc. (K001870) length of cable and stiffness does not permit looping. USA Instruments, Inc. Excalibur 9000…
Usa Instruments, Inc.2000—
*K964531Profile 70000 Quadrature Volume Neck Coil
Summary page 2
…o the Profile 7000 Quadrature Volume Neck Coil manufactured by USA Instruments, Inc. (K964531) Coil Design: Receive-only quadrature - Similar to the Millennium 9000 Phased Array phased array coil. Neur…
Us Asia Instruments, Inc.1997—

Also cleared against K001870: 6 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K041487QD Head Speeder with Speeder NV AttachmentUsa Instruments, Inc.20045

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K041487 (Usa Instruments, Inc., 2004) has gone furthest, with 5 descendants of its own.
  • 6 other devices also cite its predicate K001870.

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?

The Excalibur 9000 TotalSENSETMQuad Array Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Excalibur 9000 TotalSENSETMQuad Array Head Coil is designed for use with the Toshiba 1.5T scanner manufactured by Toshiba Medical Systems. Anatomic Regions: brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. Nuclei…

Read the full statement (158 words)

The Excalibur 9000 TotalSENSETMQuad Array Head Coil is designed to provide Magnetic Resonance Images of the brain, upper cervical spine, and the soft tissues and vasculature of the head and neck. The Excalibur 9000 TotalSENSETMQuad Array Head Coil is designed for use with the Toshiba 1.5T scanner manufactured by Toshiba Medical Systems.

Anatomic Regions: brain, upper cervical spine, and the soft tissues and vasculature of the head and neck.

Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The 1.5T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Indications for use as stated in the FDA summary.

Also cleared against K001870

6 other devices cite the same predicate.

  • K0526211.5T 16 Channel Brain-Spine Array CoilUsa Instruments, Inc. · 20051 recall
  • K042342Millennium Iii 3T-8-Channel Neurovascular CoilUsa Instruments, Inc. · 2004
  • K041487QD Head Speeder with Speeder NV AttachmentUsa Instruments, Inc. · 2004
  • K0326183.0T 8 Channel Neurovascular (NV) Array CoilUsa Instruments, Inc. · 2003
  • K032415Millennium Iii 4 Channel Neurovascular CoilUsa Instruments, Inc. · 2003
  • K021141Millennium 5000 Meurovascular CoilUsa Instruments, Inc. · 2002

More from Usa Instruments, Inc.

64 FDA decisions under this applicant name. See the company

  • K052916Usa Instruments 3.0T Brain/Spine ArrayUsa Instruments, Inc. · 20051 recall
  • K0526211.5T 16 Channel Brain-Spine Array CoilUsa Instruments, Inc. · 20051 recall
  • K0525841.5T 12 Channel Body ArrayUsa Instruments, Inc. · 2005
  • K0525853T HD Breast ArrayUsa Instruments, Inc. · 20055 recalls
  • K050728Open Breast Coil (Obc) with Biopsy PlatesUsa Instruments, Inc. · 2005

Recent decisions in MOS

The MOS category page

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  • K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS…Philips Medical Systems Nederland B.V. · 2026
  • K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS…Philips Medical Systems Nederland B.V. · 2026
  • K2609470.55T 12Ch Breast CoilNeocoil, LLC · 2026
  • K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd. · 2026

https://510kreport.com/device/K022582 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022582: Excalibur 9000 Totalsense Quad Head Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022582

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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