Model 311GE-64: Whole Volume Neck Coil

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K914535 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Medical Advances, Inc. →

• What is the Model 311GE-64 Whole Volume Neck Coil used for?

  The Model 311GE-64 Whole Volume Neck Coil is designed for use in radiology departments for magnetic resonance imaging procedures. It is specifically engineered to provide whole volume imaging of the neck area during MRI scans.

• Is the Model 311GE-64 Neck Coil reusable or single-use?

  The Model 311GE-64 Whole Volume Neck Coil is intended for single-use applications only. This design ensures optimal performance and eliminates the need for sterilization between uses, maintaining patient safety and image quality.

• What regulatory approvals does the Model 311GE-64 Neck Coil have?

  The Model 311GE-64 Whole Volume Neck Coil has received FDA 510(k) clearance with number K914535 on November 27, 1991. It is classified as a Class II medical device and regulated under product code 892.1000.

• How is the Model 311GE-64 Neck Coil supplied?

  The device is supplied as a whole volume neck coil, ready for immediate use in MRI procedures. It is manufactured by Medical Advances, Inc. and distributed through their network to radiology departments and medical facilities.