Adaptive Image Receive (AIR) Anterior Array (AA) coil 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 strictuly 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

Table 1. Shipping contents for AIR AA coil

Part number	Description	Quantity
5030100	3T AIR Anterior Array (AA) with Cable	1
5860242	3T AIR Anterior Array (AA) Redesign with Cable	1 Note: Part of Air Anterior Array (AA) Coil Redesign 5030192
5775320	AIR Anterior Array (AA) Name Translation Labels	1
5492658	Coil Name Language Translation Label Instruction Sheet	1
5746694-500	AIR Anterior Array (AA) Operator Manual Packet	1
5495812	Patient Strap, MRPET Anterior Array (AA)	4