# K033353: Modification to Liberty 5000 Breast Coil with Disposable Biopsy Plates

- Pathway: 510(k) (Special)
- Applicant: Usa Instruments, Inc.
- Decided: Nov 14, 2003 after 25 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: 6 generations back to K931544 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022007: Liberty 5000 Breast Coil with Disposable Biopsy Plates, Usa Instruments, Inc. (2002) Summary page 2.

## Indications for use
The Liberty 5000 Breast Coil with Disposable Biopsy Plates 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 Plates is designed for use with the Hitachi Airis II 0.3T scanner. The indications for use are the same as for standard imaging: The Airis II 0.3T 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/K033353
Methodology: https://510kreport.com/methodology