# K022007: Liberty 5000 Breast Coil with Disposable Biopsy Plates

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Nov 4, 2002 after 138 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931544 (1993). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 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)
- K993776: Obc-300 Breast Array Coil, Mri Devices Corp. (1999) Summary page 2.
- K983342: MR Guided Procedures (MRGP) Basic Package, Philips Medical Systems (Cleveland), Inc. (1998) Summary page 2.

## Most influential descendants
- K050728: Open Breast Coil (Obc) with Biopsy Plates (2005), 0 descendants of its own
- K033353: Modification to Liberty 5000 Breast Coil with Disposable Biopsy Plates (2003), 0 descendants of its own

## Indications for use
The Liberty 5000 Breast Coil with Disposable Biopsy Plate is designed to provide Magnetic Resonance Images of the breast anatomy and aid in guidance during biopsy procedures. The Liberty 5000 Breast Coil with Disposable Biopsy Plate is designed for use with the Hitachi Altaire 0.7T scanner. The indications for use are the same as for standard imaging: The Altaire 0.7T 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/K022007
Methodology: https://510kreport.com/methodology