# K052585: 3T HD Breast Array

- Pathway: 510(k) (Special)
- Applicant: Usa Instruments, Inc.
- Decided: Oct 4, 2005 after 14 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001582 (2000). 2 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041695: Liberty 9000 8-CH Breast Coil with Disposable Biopsy Plate, Usa Instruments, Inc. (2004) Summary page 1.

## Most influential descendants
- K173377: 3.0T 16ch Breast Coil (2017), 3 descendants of its own
- K182958: 1.5T 16ch Breast Coil (2018), 2 descendants of its own
- K061715: Mrgfus General Purpose and Breast Coil (2006), 2 descendants of its own
- 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 (2022), 1 descendant of its own
- K083434: TT1 General Purpose Coil (2008), 1 descendant of its own

## Recalls of this device
- Jan 31, 2007 · Not classified · Z-0517-2007: The packaging used for the Breast Biopsy plate may exhibit small holes or tears
- Jan 31, 2007 · Not classified · Z-0519-2007: The packaging used for the Breast Biopsy plate may exhibit small holes or tears.
- Jan 31, 2007 · Not classified · Z-0516-2007: The packaging used for the Breast Biopsy plate may exhibit small holes or tears
- Jan 31, 2007 · Not classified · Z-0518-2007: The packaging used for the Breast Biopsy plate may exhibit small holes or tears
- Nov 21, 2006 · Not classified · Z-0505-2007: The packaging used for the Breast Biopsy Plate may exhibit small holes or tears.

## Indications for use
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.

Source page: https://510kreport.com/device/K052585
Methodology: https://510kreport.com/methodology