# K060547: Access Breast Coil 4/SMS

- Pathway: 510(k) (Traditional)
- Applicant: Confirma, Inc.
- Decided: Mar 29, 2006 after 28 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: 1 generation back to K022488 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022488: Model Obc-63 Breast Array Coil, Mri Devices Corp. (2002) Summary page 3.

## Indications for use
The Access Breast Coil 4/SMS is a 4-channel, phased array, receive-only RF coil used in conjunction with a magnetic resonance imager (MRI) 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 acquiring diagnostic breast MRI studies and interventional breast MRI studies for localization of lesions, biopsies and other interventional procedures.

Source page: https://510kreport.com/device/K060547
Methodology: https://510kreport.com/methodology