# K973787: Medrad 1.5T Extremity Array

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Dec 30, 1997 after 85 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The 1.5T Extremity Array is a four-coil phased array device which operates in the transmit-receive mode. The device is intended to excite and receive signal from hydrogen protons for diagnostic quelity radiographic images when used with GE 1.5T Signa Advantage, Horizon and Horizon LX scanner(s) during MR imaging.

Source page: https://510kreport.com/device/K973787
Methodology: https://510kreport.com/methodology