# K960901: Medrad Phased Array 1.5T Shoulder Imaging Surface Coil

- Pathway: 510(k) (Traditional)
- Applicant: Medrad, Inc.
- Decided: May 29, 1996 after 85 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 K892235 (1989). 2 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 9 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 1.
- K923025: Signa Breast Coil and Array Accessory, GE Medical Systems (1992) Summary page 3.

## Most influential descendants
- K984257: Medrad Phased Array Neurovascular Coil (1999), 3 descendants of its own
- K023596: Medrad 8-Receiver Phased Array Neurovascular Coil (2002), 2 descendants of its own
- K093689: 1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for Siemans (2010), 0 descendants of its own
- K052827: Modification to Medrad 8-Receiver Phased Array Neurovascular Coil for Siemens (2005), 0 descendants of its own
- K984159: Medrad Quadrature CTL Array Coil (1999), 0 descendants of its own

## 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 either the right or left shoulder region with a specific size and shape to facilitate placement on the anatomy area of interest. This placement results 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 antarior and posterior musculoskeletal area of the shoulder. This includes the rotator cuff, humeral head, glenoid, glenoid labrum and glenoid cavity. The region runs superior through the clavicle and acromion and inferior through the infraspinatus. It also extends posterior to the lateral margin. The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is intended for use in physician diagnosis of impingement syndrome, glenoid labrum tendon tears, rotator cuff tears, edema secondary to the aforementioned, retraction of the supraspinatus muscle and trauma of the long head of the biceps tendon. Patient fitness and suitability for MRI must be cletermined by the individual physician trained in the field of Diagnostic Magnetic Resonance Imaging.

Source page: https://510kreport.com/device/K960901
Methodology: https://510kreport.com/methodology