# K984159: Medrad Quadrature CTL Array Coil

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Jan 12, 1999 after 54 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 K892235 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954952: Medrad/Hitachi 1.5T Quad C-Spine Surface Coil, Medrad, Inc. (1996) Summary page 2.
- K902663: GE Quadrature T/L Spine Surf Coil, M1085AP/M1285AP, General Electric Co. (1990) Summary page 2.
- K960901: Medrad Phased Array 1.5T Shoulder Imaging Surface Coil, Medrad, Inc. (1996) Summary page 2.

## Indications for use
The Medrad Quad CTL Array Coil is a receive only coil intended to be used MRI Scanncr Systems for imaging of the cervical, thoracic and lumbar regions of the spinc anatomy. The Medrad Quad CTI. Array Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Magnetic Resonance I'naging.

Source page: https://510kreport.com/device/K984159
Methodology: https://510kreport.com/methodology