510(k) · Cleared
Cleared16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neocoil, LLC · MOS Coil, Magnetic Resonance, Specialty
Cleared on Oct 14, 2022 as substantially equivalent to K173377 (Neocoil, LLC, 2017) and 1 other predicate after a 66-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Oct 14, 2022
- Review
- 66 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K001582 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK001582 Liberty 9000 Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2000
- 4 generations backK041695 Liberty 9000 8-CH Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2004 · Recalled
- 3 generations backK052585 3T HD Breast ArrayUsa Instruments, Inc. · 2005 · Recalled
- 2 generations backK173377 3.0T 16ch Breast CoilNeocoil, LLC · 2017
- 1 generation backK182958 1.5T 16ch Breast CoilNeocoil, LLC · 2018
- This deviceK222407 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T…Neocoil, LLC · 2022
- Descendant · cites it directly · 0 of its ownK260947 0.55T 12Ch Breast CoilNeocoil, LLC · 2026
Most influential descendants
Showing 1 of 1 · See all- K2609470.55T 12Ch Breast CoilNeocoil, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001582 | Liberty 9000 Breast Coil with Disposable Biopsy Plate | Usa Instruments, Inc. | 2000 | — |
| −4 | K041695 | Liberty 9000 8-CH Breast Coil with Disposable Biopsy Plate | Usa Instruments, Inc. | 2004 | 5 |
| −3 | K052585 | 3T HD Breast Array | Usa Instruments, Inc. | 2005 | 5 |
| −2 | K173377 | 3.0T 16ch Breast Coil | Neocoil, LLC | 2017 | — |
| −1 | K182958 | 1.5T 16ch Breast Coil | Neocoil, LLC | 2018 | — |
| 0 (this device) | K222407 | 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast… | Neocoil, LLC | 2022 | — |
| +1 | K260947 | 0.55T 12Ch Breast Coil | Neocoil, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173377 | 3.0T 16ch Breast CoilSummary page 4…21 CFR 892.1000, Magnetic resonance diagnostic device, Product Code MOS Predicate Device 3.0T 16ch Breast Coil, K173377, cleared on 11/28/2017, manufactured by NeoCoil, LLC Reference Device 1.5T 16ch Breast Coil, K182958, cleared on 11/16/… | 2017 |
| * | K182958 | 1.5T 16ch Breast CoilSummary page 4…Code MOS Predicate Device 3.0T 16ch Breast Coil, K173377, cleared on 11/28/2017, manufactured by NeoCoil, LLC Reference Device 1.5T 16ch Breast Coil, K182958, cleared on 11/16/2018, manufactured by NeoCoil, LLC Device Description The NeoCoil 3.0T 16ch Breast Coil is a phased a… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260947 | 0.55T 12Ch Breast Coil | 2026 | 0 |
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 22 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K260947 (Neocoil, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K173377.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The NeoCoil 16ch Breast Coils are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended for use by trained medical professionals, in combination with and controlled by compatible 1.5T or 3T/3.0T MRI system software. The NeoCoil 16ch Breast Coils 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 16ch…
Read the full statement (102 words)
The NeoCoil 16ch Breast Coils are Magnetic Resonance Imaging (MRI) RF Receive-Only Coils intended for use by trained medical professionals, in combination with and controlled by compatible 1.5T or 3T/3.0T MRI system software.
The NeoCoil 16ch Breast Coils 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 16ch 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222407 · printed Nov 4, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222407
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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