# K982959: Medrad Quad C-Spine Coil, 1.5T Model, M64CSC, 1.0T Model M42CSC

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Nov 3, 1998 after 71 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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 K884369 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884369: Posterior Cervical Spine Surface Coil M1085AM, General Electric Co. (1988) Summary page 2.
- K954952: Medrad/Hitachi 1.5T Quad C-Spine Surface Coil, Medrad, Inc. (1996) Summary page 2.

## Indications for use
The Medrad Quad C-Spine Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the Area superior to the top of the sella turcica and inferior to the third thoracic vertebra The Medrad Quad C-Spine 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/K982959
Methodology: https://510kreport.com/methodology