# K982921: Medrad 0.5T, 1.0T & 1.5T Breast Coil, Models M21BRC, M42BRA, M64BRA

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Nov 3, 1998 after 76 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 K923025 (1992). 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)
- K923025: Signa Breast Coil and Array Accessory, GE Medical Systems (1992) Summary page 2.

## Indications for use
The Medrad Breast Coil is a receive only coil intended to be used MR! Scanner Systems for imaging of the breast anatomy. The Medrad Breast Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Magnetic Resonance imaging.

Source page: https://510kreport.com/device/K982921
Methodology: https://510kreport.com/methodology