510(k) · Cleared
Recalled · 20073T HD Breast Array
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Oct 4, 2005 as substantially equivalent to K041695 (Usa Instruments, Inc., 2004) after a 14-day review. Its family tree reaches back 2 generations to 2000. 8 later devices descend from it. It has been recalled 5 times.
- Decided
- Oct 4, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- MOS
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001582 (2000). 8 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK001582 Liberty 9000 Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2000
- 1 generation backK041695 Liberty 9000 8-CH Breast Coil with Disposable Biopsy PlateUsa Instruments, Inc. · 2004 · Recalled
- This deviceK052585 3T HD Breast ArrayUsa Instruments, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK173377 3.0T 16ch Breast CoilNeocoil, LLC · 2017
- Descendant · 2 generations on · 2 of its ownK182958 1.5T 16ch Breast CoilNeocoil, LLC · 2018
- Descendant · cites it directly · 2 of its ownK061715 Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK222407 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T…Neocoil, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK083434 TT1 General Purpose CoilTursiop Technologies, LLC · 2008
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K1733773.0T 16ch Breast CoilNeocoil, LLC · 2017 · cites it directly3descendants
- K1829581.5T 16ch Breast CoilNeocoil, LLC · 2018 · 2 generations on2descendants
- K061715Mrgfus General Purpose and Breast CoilInsightec Txsonics, Inc. · 2006 · cites it directly2descendants
- K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T…Neocoil, LLC · 2022 · 2 generations on1descendant
- K083434TT1 General Purpose CoilTursiop Technologies, LLC · 2008 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001582 | Liberty 9000 Breast Coil with Disposable Biopsy Plate | Usa Instruments, Inc. | 2000 | — |
| −1 | K041695 | Liberty 9000 8-CH Breast Coil with Disposable Biopsy Plate | Usa Instruments, Inc. | 2004 | 5 |
| 0 (this device) | K052585 | 3T HD Breast Array | Usa Instruments, Inc. | 2005 | — |
| +1 | K173377 | 3.0T 16ch Breast Coil | Neocoil, LLC | 2017 | — |
| +2 | K182958 | 1.5T 16ch Breast Coil | Neocoil, LLC | 2018 | — |
| +1 | K061715 | Mrgfus General Purpose and Breast Coil | Insightec Txsonics, Inc. | 2006 | — |
| +2 | K222407 | 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast… | Neocoil, LLC | 2022 | — |
| +2 | K083434 | TT1 General Purpose Coil | Tursiop Technologies, LLC | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K041695 | Liberty 9000 8-CH Breast Coil with Disposable Biopsy PlateSummary page 1…edicate: The 3.OT HD Breast Array is a modification of the existing cleared I ST Liberty 9000 8-channel Breast coil (K04 1695), with the main difference being the coil has been retuned for operation in a 3.OT… | 2004 |
What descends from it? (8)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 31, 2007 | Not classified | Z-0517-2007 | Other | The packaging used for the Breast Biopsy plate may exhibit small holes or tears |
| Jan 31, 2007 | Not classified | Z-0519-2007 | Other | The packaging used for the Breast Biopsy plate may exhibit small holes or tears. |
| Jan 31, 2007 | Not classified | Z-0516-2007 | Other | The packaging used for the Breast Biopsy plate may exhibit small holes or tears |
| Jan 31, 2007 | Not classified | Z-0518-2007 | Other | The packaging used for the Breast Biopsy plate may exhibit small holes or tears |
| Nov 21, 2006 | Not classified | Z-0505-2007 | Other | The 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?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 4.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K173377 (Neocoil, LLC, 2017) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 3.0T HD Breast Array is a receive-only RF coil, used for obtaining MR images of the breast and axillary tissue. The biopsy plates allow access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the 3.0T HD Breast Array. The indications for use are the same as for standard MR Imaging. The 3.0T HD Breast Array is designed for use with the 3.0T Signa Excite MRI scanner, manufactured by General Electric Healthcare.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052585: 3T HD Breast Array.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052585
Report an extraction error
Are you the manufacturer?
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