Anterior Array (AA) coils 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.

3.0T AA

To identify the AA coil, see the illustrations below. The AA coil should be stored on top of the coil positioner to maintain the curved shape of the AA coil.

Table 1.

Description	Part Number	Quantity
3.0T GEM Anterior Array (AA) Coil (includes patient straps)	5555167	1
GEM Anterior Array (AA) Coil Positioner	5401856	1
GEM Anterior Array (AA) System Cable Guide	5392791	2
GEM Anterior Array (AA) Asset Imaging Pad	5408165	1