# K041695: Liberty 9000 8-CH Breast Coil with Disposable Biopsy Plate

- Pathway: 510(k) (Special)
- Applicant: Usa Instruments, Inc.
- Decided: Jul 23, 2004 after 31 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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: 1 generation back to K001582 (2000). 1 ancestor in all.
9 later devices descend from it; 1 cites 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)
- K001582: Liberty 9000 Breast Coil with Disposable Biopsy Plate, Usa Instruments, Inc. (2000) Summary page 2.

## Most influential descendants
- K052585: 3T HD Breast Array (2005), 8 descendants of its own
- 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

## 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 Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed to provide Magnetic Resonance Images of the breast anatomy. The Liberty 9000 8-ch Breast Coil with Disposable Biopsy Plate is designed for use with the GE MR's Signa Excite 1.5T MRI scanner. Anatomic Regions: Breast anatomy Nuclei Excited: Hydrogen The indications for use are the same as for standard imaging: The Signa Excite 1.5T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K041695
Methodology: https://510kreport.com/methodology