510(k) Report

510(k) · Cleared

Cleared

0.55T 12Ch Breast Coil

K260947510(k) SpecialCleared Apr 23, 202631-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

Neocoil, LLC · MOS Coil, Magnetic Resonance, Specialty

Cleared on Apr 23, 2026 as substantially equivalent to K222407 (Neocoil, LLC, 2022) after a 31-day review. Its family tree reaches back 6 generations to 2000.

Decided
Apr 23, 2026
Review
31 days
Class
Class II
Product code
MOS
Recalls
None
Predicates
1

Its longest line of descent runs back 6 generations to K001582 (2000). No later device cites it as a predicate yet.

K001582 · Liberty 9000 Breast Coil with Disposable Biopsy Plate · Usa Instruments, Inc. · 2000K041695 · Liberty 9000 8-CH Breast Coil with Disposable Biopsy Plate · Usa Instruments, Inc. · 2004 · recalledK052585 · 3T HD Breast Array · Usa Instruments, Inc. · 2005 · recalledK173377 · 3.0T 16ch Breast Coil · Neocoil, LLC · 2017K182958 · 1.5T 16ch Breast Coil · Neocoil, LLC · 2018K222407 · 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil · Neocoil, LLC · 2022200020052010201520202025
K222407 · 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil · Neocoil, LLC · 2022K182958 · 1.5T 16ch Breast Coil · Neocoil, LLC · 2018K173377 · 3.0T 16ch Breast Coil · Neocoil, LLC · 2017K052585 · 3T HD Breast Array · Usa Instruments, Inc. · 2005 · recalledK041695 · Liberty 9000 8-CH Breast Coil with Disposable Biopsy Plate · Usa Instruments, Inc. · 2004 · recalledK001582 · Liberty 9000 Breast Coil with Disposable Biopsy Plate · Usa Instruments, Inc. · 2000−50
  1. Root · 6 generations backK001582 Liberty 9000 Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2000
  2. 5 generations backK041695 Liberty 9000 8-CH Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2004 · Recalled
  3. 4 generations backK052585 3T HD Breast ArrayUsa Instruments, Inc. · 2005 · Recalled
  4. 3 generations backK173377 3.0T 16ch Breast CoilNeocoil, LLC · 2017
  5. 2 generations backK182958 1.5T 16ch Breast CoilNeocoil, LLC · 2018
  6. 1 generation backK222407 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T…Neocoil, LLC · 2022
  7. This deviceK260947 0.55T 12Ch Breast CoilNeocoil, LLC · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K001582Liberty 9000 Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc.2000—
−5K041695Liberty 9000 8-CH Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc.20045
−4K0525853T HD Breast ArrayUsa Instruments, Inc.20055
−3K1733773.0T 16ch Breast CoilNeocoil, LLC2017—
−2K1829581.5T 16ch Breast CoilNeocoil, LLC2018—
−1K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast…Neocoil, LLC2022—
0 (this device)K2609470.55T 12Ch Breast CoilNeocoil, LLC2026—
FIG. 1 — Lineage of K260947, 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 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
*K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T…
Summary page 5
…onance Specialty Coil • Classification name: 21 CFR 892.1000, Magnetic resonance diagnostic device, Product Code MOS Predicate Device 1.5T and 3T 16ch Breast Coil, K222407, cleared on 10/14/2022, manufactured by NeoCoil, LLC Device Description The NeoCoil 0.55T 12Ch Breast Coil is similar in physi…
Neocoil, LLC2022—

What descends from it?

No later submission names this one as a predicate yet.

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 26 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
  • 2 of the 6 ancestors have a recall of any class.

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. 2026, this device’s year, is highlighted.

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 NeoCoil 12Ch Breast Coil is a Magnetic Resonance Imaging (MRI) RF Receive-Only Coil intended for use by trained medical professionals, in combination with and controlled by compatible 0.55T MRI system software.

The NeoCoil 12Ch Breast Coil can be used with compatible ancillary components, accessories, and/or devices to provide access to breast anatomy for diagnostic or interventional planning/procedures.

When used as intended, the 12Ch Breast Coil provides information used by the MRI system to produce diagnostic and/or interventional planning images of the breast, axilla, and chest wall. The images produced are interpreted by medical professionals as part of clinical decision making.

Indications for use as stated in the FDA summary.

More from Neocoil, LLC

17 FDA decisions under this applicant name. See the company

  • K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil…Neocoil, LLC · 2022
  • K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch…Neocoil, LLC · 2022
  • K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder CoilNeocoil, LLC · 2020
  • K1829581.5T 16ch Breast CoilNeocoil, LLC · 2018
  • K173409Wireless Audio SystemNeocoil, LLC · 2018

Recent decisions in MOS

The MOS category page

  • K262813InkSpace Imaging Small Body Array (SBA12PH15x)Inkspace Imaging, Inc. · 2026
  • 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
  • K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd. · 2026
  • K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S…Shenzhen RF Tech Co., Ltd. · 2026

https://510kreport.com/device/K260947 · printed Nov 6, 2026

Cite this page

510(k) Report. “K260947: 0.55T 12Ch Breast Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260947

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Record history
  • FDA decision record loaded Oct 30, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026