510(k) Report

510(k) · Cleared

Recalled · 2007

Liberty 9000 8-CH Breast Coil with Disposable Biopsy Plate

K041695510(k) SpecialCleared Jul 23, 200431-day reviewClass II21 CFR 892.1000Recalls 5

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

Usa Instruments, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jul 23, 2004 as substantially equivalent to K001582 (Usa Instruments, Inc., 2000) after a 31-day review. Its family tree reaches back 1 generation to 2000. 9 later devices descend from it. It has been recalled 5 times.

Decided
Jul 23, 2004
Review
31 days
Class
Class II
Product code
LNH
Recalls
5
Predicates
1

Its longest line of descent runs back 1 generation to K001582 (2000). 9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2007: 1 descendant cleared2017: 1 descendant cleared2006: 1 descendant cleared2008: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2011: 1 descendant cleared2026: 1 descendant clearedReference device: K993776 · Obc-300 Breast Array Coil · Mri Devices Corp. · 1999Reference device: K983342 · MR Guided Procedures (MRGP) Basic Package · Philips Medical Systems (Cleveland), Inc. · 1998Reference device: K031172 · Spirit Iii Totalsense Cardiac Coil · Usa Instruments, Inc. · 2003Reference device: K980157 · Premier 7000 CTL Spine Coil · Usa Instruments, Inc. · 1998K001582 · Liberty 9000 Breast Coil with Disposable Biopsy Plate · Usa Instruments, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants K001582 · Liberty 9000 Breast Coil with Disposable Biopsy Plate · Usa Instruments, Inc. · 20000
  1. Root · 1 generation backK001582 Liberty 9000 Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2000
  2. This deviceK041695 Liberty 9000 8-CH Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2004
  3. Descendant · cites it directly · 8 of its ownK052585 3T HD Breast ArrayUsa Instruments, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK173377 3.0T 16ch Breast CoilNeocoil, LLC · 2017
  5. Descendant · 3 generations on · 2 of its ownK182958 1.5T 16ch Breast CoilNeocoil, LLC · 2018
  6. Descendant · 2 generations on · 2 of its ownK061715 Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006
  7. Descendant · 3 generations on · 1 of its ownK222407 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T…Neocoil, LLC · 2022

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 12008: 12011: 12017: 12018: 12022: 12026: 1
2005high 1 (2005) · low 0 (2009)2026

Most influential descendants

Showing 5 of 9 · See all
  • K0525853T HD Breast ArrayUsa Instruments, Inc. · 2005 · cites it directly8descendants
  • K1733773.0T 16ch Breast CoilNeocoil, LLC · 2017 · 2 generations on3descendants
  • K1829581.5T 16ch Breast CoilNeocoil, LLC · 2018 · 3 generations on2descendants
  • K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006 · 2 generations on2descendants
  • K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T…Neocoil, LLC · 2022 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001582Liberty 9000 Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc.2000—
0 (this device)K041695Liberty 9000 8-CH Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc.2004—
+1K0525853T HD Breast ArrayUsa Instruments, Inc.20055
+2K1733773.0T 16ch Breast CoilNeocoil, LLC2017—
+3K1829581.5T 16ch Breast CoilNeocoil, LLC2018—
+2K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc.2006—
+3K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast…Neocoil, LLC2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
200810
201110
201710
201810
202210
202610
FIG. 1 — Lineage of K041695, 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), 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
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
*K001582Liberty 9000 Breast Coil with Disposable Biopsy Plate
Summary page 2
…st Coil with diagnostic purposes. The coil has a Disposable Biopsy Plate manufactured by USA biopsy plate that allows access to the Instruments, Inc. (K001582) breast. -Similar to OBC-300 Breast Array Coil…
Usa Instruments, Inc.2000—
†K993776Obc-300 Breast Array CoilMri Devices Corp.1999—
†K983342MR Guided Procedures (MRGP) Basic PackagePhilips Medical Systems (Cleveland), Inc.1998—
†K031172Spirit Iii Totalsense Cardiac CoilUsa Instruments, Inc.2003—
†K980157Premier 7000 CTL Spine CoilUsa Instruments, Inc.1998—

Also cleared against K001582: 1 other device →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K0525853T HD Breast ArrayUsa Instruments, Inc.20058

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 31, 2007Not classifiedZ-0517-2007OtherThe packaging used for the Breast Biopsy plate may exhibit small holes or tears
Jan 31, 2007Not classifiedZ-0519-2007OtherThe packaging used for the Breast Biopsy plate may exhibit small holes or tears.
Jan 31, 2007Not classifiedZ-0516-2007OtherThe packaging used for the Breast Biopsy plate may exhibit small holes or tears
Jan 31, 2007Not classifiedZ-0518-2007OtherThe packaging used for the Breast Biopsy plate may exhibit small holes or tears
Nov 21, 2006Not classifiedZ-0505-2007OtherThe packaging used for the Breast Biopsy Plate may exhibit small holes or tears.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K052585 (Usa Instruments, Inc., 2005) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K001582.

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?

The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed to provide Magnetic Resonance Images of the breast anatomy. The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed for use with the GE MR's Signa Excite 1.5T MRI scanner. Anatomic Regions: Breast anatomy Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Signa Excite 1.5T system is indicated for use as an NMR device that…

Read the full statement (138 words)

The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed to provide Magnetic Resonance Images of the breast anatomy. The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed for use with the GE MR's Signa Excite 1.5T MRI scanner.

Anatomic Regions: Breast anatomy

Nuclei Excited: Hydrogen

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

The Signa Excite 1.5T 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 K001582

1 other device cites the same predicate.

  • K022007Liberty 5000 Breast Coil with Disposable Biopsy PlatesUsa 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 LNH

The LNH category page

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https://510kreport.com/device/K041695 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041695: Liberty 9000 8-CH Breast Coil with Disposable Biopsy Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041695

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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