# K982916: Medrad 1.5T, 1.0T & 0.5T Shoulder Coil, Models M64SHC, M42SHC, M21SHC

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Oct 29, 1998 after 71 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 K892235 (1989). 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)
- K892235: GE Shoulder Surface Coil, Cat. #M1085AN, General Electric Co. (1989) Summary page 2.

## Indications for use
The Medrad Shoulder Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the shoulder anatomy. The Medrad Shoulder 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/K982916
Methodology: https://510kreport.com/methodology