510(k) · Cleared
Cleared3.0T 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 Nov 28, 2017 as substantially equivalent to K052585 (Usa Instruments, Inc., 2005) after a 29-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it.
- Decided
- Nov 28, 2017
- Review
- 29 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001582 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK001582 Liberty 9000 Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2000
- 2 generations backK041695 Liberty 9000 8-CH Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2004 · Recalled
- 1 generation backK052585 3T HD Breast ArrayUsa Instruments, Inc. · 2005 · Recalled
- This deviceK173377 3.0T 16ch Breast CoilNeocoil, LLC · 2017
- Descendant · cites it directly · 2 of its ownK182958 1.5T 16ch Breast CoilNeocoil, LLC · 2018
- Descendant · cites it directly · 1 of its ownK222407 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T…Neocoil, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK260947 0.55T 12Ch Breast CoilNeocoil, LLC · 2026
Most influential descendants
Showing 3 of 3 · See all- K1829581.5T 16ch Breast CoilNeocoil, LLC · 2018 · cites it directly2descendants
- K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T…Neocoil, LLC · 2022 · cites it directly1descendant
- K2609470.55T 12Ch Breast CoilNeocoil, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001582 | Liberty 9000 Breast Coil with Disposable Biopsy Plate | Usa Instruments, Inc. | 2000 | — |
| −2 | K041695 | Liberty 9000 8-CH Breast Coil with Disposable Biopsy Plate | Usa Instruments, Inc. | 2004 | 5 |
| −1 | K052585 | 3T HD Breast Array | Usa Instruments, Inc. | 2005 | 5 |
| 0 (this device) | K173377 | 3.0T 16ch Breast Coil | Neocoil, LLC | 2017 | — |
| +1 | K182958 | 1.5T 16ch Breast Coil | Neocoil, LLC | 2018 | — |
| +1 | K222407 | 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast… | Neocoil, LLC | 2022 | — |
| +2 | K260947 | 0.55T 12Ch Breast Coil | Neocoil, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052585 | 3T HD Breast ArraySummary page 5…r use in a manner that is similar to the predicate device described in this submission. 5.7. Predicate Device • 3.0T HD Breast Array, K052585, as cleared on 10/04/2005. 5.8. Comparison to Predicate The NeoCoil 3.0T 16ch Breast Coil is similar in phys… | 2005 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K182958 (Neocoil, LLC, 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K052585.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
To be used in conjunction with GEHC 3.0T Magnetic Resonance Scanners to produce diagnostic and interventional planning images of the breast that can be interpreted by a trained physician. When used with biopsy components, this device permits access to the breast anatomy for interventional procedures that can be performed by a trained physician.
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/K173377 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173377: 3.0T 16ch Breast Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173377
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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