# K052045: Access Breast Coil

- Pathway: 510(k) (Traditional)
- Applicant: Confirma, Inc.
- Decided: Aug 24, 2005 after 27 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: 2 generations back to K003340 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000993: Liberty 9000 Breast Coil, Usa Instruments, Inc. (2000) Summary page 3.
- K013985: Machnet Bilateral Open Breast Coil. Catalog # Mics-GSXX, Machnet BV (2002) Summary page 3.
- K041481: Model BBC-127 Biopsy Breast Coil, Mri Devices Corp. (2004) Summary page 3.

## Indications for use
The Access Breast Coil is a 7-channel, phased array, receive-only RF coil, used in conjunction with a magnetic resonance scanner to produce diagnostic and interventional images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician. The device is designed to aid the physician in MR-guided breast biopsy, localization of lesions, and interventional procedures, providing lateral, medial and cranial-caudal access to the breast.

Source page: https://510kreport.com/device/K052045
Methodology: https://510kreport.com/methodology