510(k) Report

510(k) · Cleared

Cleared

3.0T 8 Channel Neurovascular (NV) Array Coil

K032618510(k) SpecialCleared Sep 12, 200317-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 Sep 12, 2003 as substantially equivalent to K001870 (Usa Instruments, Inc., 2000) after a 17-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.

Decided
Sep 12, 2003
Review
17 days
Class
Class II
Product code
MOS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001870 (2000). 5 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2009: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant clearedReference device: K023247 · Champion 5000 Peripheral Vascular Coil · Usa Instruments, Inc. · 2002K001870 · Millennium 9000 Phased Array Neurovascular Coil · Usa Instruments, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 1 descendant K001870 · Millennium 9000 Phased Array Neurovascular Coil · Usa Instruments, Inc. · 20000+5
  1. Root · 1 generation backK001870 Millennium 9000 Phased Array Neurovascular CoilUsa Instruments, Inc. · 2000
  2. This deviceK032618 3.0T 8 Channel Neurovascular (NV) Array CoilUsa Instruments, Inc. · 2003
  3. Descendant · cites it directly · 4 of its ownK052916 Usa Instruments 3.0T Brain/Spine ArrayUsa Instruments, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK093348 3.0T 16 Channel Head Neck Spine CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2009
  5. Descendant · 3 generations on · 2 of its ownK113365 Infant ArrayAdvanced Imaging Research Dba Sree Medical Systems · 2012
  6. Descendant · 4 generations on · 1 of its ownK140998 Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim CoilQuality Electrodynamics, LLC · 2014
  7. Descendant · 5 generations on · 0 of its ownK183186 Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular…Shanghai United Imaging Healthcare Co., Ltd. · 2019

Most influential descendants

Showing 5 of 5 · See all
  • K052916Usa Instruments 3.0T Brain/Spine ArrayUsa Instruments, Inc. · 2005 · cites it directly4descendants
  • K0933483.0T 16 Channel Head Neck Spine CoilGe Healthcare Coils (Usa Instruments, Inc.) · 2009 · 2 generations on3descendants
  • K113365Infant ArrayAdvanced Imaging Research Dba Sree Medical Systems · 2012 · 3 generations on2descendants
  • K140998Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim CoilQuality Electrodynamics, LLC · 2014 · 4 generations on1descendant
  • K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd. · 2019 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001870Millennium 9000 Phased Array Neurovascular CoilUsa Instruments, Inc.2000—
0 (this device)K0326183.0T 8 Channel Neurovascular (NV) Array CoilUsa Instruments, Inc.2003—
+1K052916Usa Instruments 3.0T Brain/Spine ArrayUsa Instruments, Inc.20051
+2K0933483.0T 16 Channel Head Neck Spine CoilGe Healthcare Coils (Usa Instruments, Inc.)2009—
+3K113365Infant ArrayAdvanced Imaging Research Dba Sree Medical Systems2012—
+4K140998Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim CoilQuality Electrodynamics, LLC2014—
+5K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil…Shanghai United Imaging Healthcare Co., Ltd.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200910
201210
201410
201910
FIG. 1 — Lineage of K032618, 2000–2019Source: 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? (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
*K001870Millennium 9000 Phased Array Neurovascular Coil
Our reading of the summary gave K001807, FDA’s number for Tissue Marker (Advanced Uroscience, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Millennium 9000 Phased Array Neurovascular coil”.
Usa Instruments, Inc.2000—
†K023247Champion 5000 Peripheral Vascular CoilUsa Instruments, Inc.2002—

Also cleared against K001870: 6 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K052916Usa Instruments 3.0T Brain/Spine ArrayUsa Instruments, Inc.20054

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?

  • Its one ancestor has no recall.
  • Of its descendants, K052916 (Usa Instruments, Inc., 2005) has gone furthest, with 4 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 3.OT 8 Channel Neurovascular (NV) Array Coil is designed to provide Magnetic: Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. The 3.OT 8 Channel Neurovascular (NV) Array Coil is designed for use with the GE 3,OT scanner manufactured by GE Medical Systems, Inc. Anatomic Regions: brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest Nuclei Excited: Hydrogen…

Read the full statement (160 words)

The 3.OT 8 Channel Neurovascular (NV) Array Coil is designed to provide Magnetic: Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. The 3.OT 8 Channel Neurovascular (NV) Array Coil is designed for use with the GE 3,OT scanner manufactured by GE Medical Systems, Inc.

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

Nuclei Excited: Hydrogen

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

The 3.OT 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 T I, 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
  • K032415Millennium Iii 4 Channel Neurovascular CoilUsa Instruments, Inc. · 2003
  • K022582Excalibur 9000 Totalsense Quad Head Array CoilUsa Instruments, Inc. · 2002
  • 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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  • K2609470.55T 12Ch Breast CoilNeocoil, LLC · 2026
  • K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd. · 2026

https://510kreport.com/device/K032618 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032618: 3.0T 8 Channel Neurovascular (NV) Array Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032618

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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