Posterior Cervical Spine Surface Coil M1085AM

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

510(k) Number

K884369 ↗

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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• What is the Posterior Cervical Spine Surface Coil M1085AM used for?

  The Posterior Cervical Spine Surface Coil M1085AM is a medical imaging device designed for high-resolution MRI of the cervical spine. It improves signal-to-noise ratio through its flexible coil design, enhancing imaging capabilities specifically for the posterior cervical spine region in radiology settings.

• How is the Posterior Cervical Spine Surface Coil M1085AM supplied?

  The device is supplied by General Electric Co. and is classified as a System, Nuclear Magnetic Resonance Imaging device under product code LNH. It is intended for use in radiology settings for MRI imaging procedures.

• What is the regulatory status of the Posterior Cervical Spine Surface Coil M1085AM?

  The device received FDA 510(k) clearance with number K884369 on November 28, 1988. It is classified as Class II with special controls and was determined to be substantially equivalent to predicate devices through the traditional clearance pathway.

• Is the Posterior Cervical Spine Surface Coil M1085AM reusable or single-use?

  The device data does not specify whether the Posterior Cervical Spine Surface Coil M1085AM is designed for single-use or multiple reuse. For specific usage instructions regarding sterilization and reuse, please consult the manufacturer's documentation or contact General Electric Co. directly.