# K964854: Medrad Phased Array 1.5T Shoulder Imaging Surgace Coil

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: Feb 11, 1997 after 70 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960901: Medrad Phased Array 1.5T Shoulder Imaging Surface Coil, Medrad, Inc. (1996) Summary page 2.

## Indications for use
The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is for use only with the GEMS family of Super Conductor MR Systems. An anterior loop pair is combined with a posterior loop. The coil is designed to receive RF excitation from the protons of the hydrogen nuclei as a result of the scanner exciting these protons. The coil is designed for anatomical imaging of shoulder region and the upper and lower extremeties with a specific size and shape to facilitate placement on the anatomy area of interest. This placement resuits in a higher Signal To Noise Ratio(SNR) in the region near the surface coil. The greater SNR permits more effective imaging through the use of a smaller FOV and thinner slices. The intended ROI for imaging includes the anterior and posterior musculoskeletal area of the shoulder and the upper and lower extremeties. The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is intended to aid physician diagnosis in the shoulder, upper, and lower extremety regions. Patient fitness and suitability for MR! must be determined by the individual physician trained in the field of Diagnostic Magnetic Resonance Imaging.

Source page: https://510kreport.com/device/K964854
Methodology: https://510kreport.com/methodology