1.5T Shoulder Introduction

The performance of any modifications and/or repairs that have not been evaluated and approved by GEHC Coils Engineering may cause the device to be adulterated within the meaning of section 501(h) of the Food, Drug and Cosmetic Act, 21 U.S.C. § 351(h) and is strictly prohibited.

Specifically, unapproved modifications may impact the safety claims of the device pertaining to the patient/user in relation to shock, biocompatibility, flammability, biological, and thermal regulations. Any changes to materials outside of those within the products service documentation may be considered adulterated and can be in violation of good manufacturing practice requirements.

Product Identification and Shipping List

To identify the Shoulder coil, see the illustrations below.Figure 1.

Figure 2 shows a picture of the 1.5T Shoulder Coil.

Table 1. Shipping List

Description	Part Number	Quantity
1.5T Shoulder Coil	5344905	1
Shoulder Coil Patient Pad	2423514	1
Shoulder Coil Spacer Pad	2423516	1
Kizuna Shoulder Coil Phantom Holder	5694345	1
Shoulder Coil Strap Set	5368390	1
OP GUIDE CD PKT,1.5T and 3T SHOULDER	2422148-500	1
1.5T Phased Array Shoulder Coil Translation Label	5490496-25	1
Coil Name Language Translation Label Instruction Sheet	5492658	1