MEDRAD QUAD T/L COIL - M42TLC

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

510(k) Number

K982919 ↗

FDA Product Code

MOS

Models / Variants

M64TLC

M42TLC

M21TLC

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Mriinnervu Disposable Endorectal Cervic Coil, Catalog No. Bcr-15

  Class II

  FDA 510(k) K952235 Active Cleared 26 Jun 1995

• Medrad Phased Array 1.5T Shoulder Imaging Surface Coil

  Class II

  FDA 510(k) K960901 Active Cleared 29 May 1996

• Benzalkonium-Heparin Coated Guidewires

  Class II

  FDA 510(k) K802473 Active Cleared 12 Nov 1980

• Medrad Counterpoise System

  Class II

  FDA 510(k) K944983 Active Cleared 29 Nov 1994

• Medrad Fluoroscopic Video Enhancement System

  Class II

  FDA 510(k) K884317 Active Cleared 20 Dec 1988

• Mrinnervu Endorectal Prostate Coil

  Class II

  FDA 510(k) K925029 Active Cleared 19 May 1993

See all devices from Medrad, Inc. →

• What is the Medrad Quad T/L Coil designed for?

  The Medrad Quad T/L Coil is a receive-only surface coil specifically engineered to improve signal reception from hydrogen nuclei during MRI scans. It is optimized for enhanced visualization of the thoracic and lumbar spine regions, making it ideal for radiology applications requiring detailed imaging of these areas. The coil amplifies signal clarity when interfaced directly with MRI scanners, aiding in diagnostic accuracy.

• How is the Medrad Quad T/L Coil supplied and intended for use?

  The Medrad Quad T/L Coil is supplied as a reusable device, meaning it is designed for repeated use in clinical MRI settings under the supervision of a physician. It is not intended for single-use applications. The coil must be handled and stored according to the manufacturer’s guidelines to ensure MRI safety and maintain operational integrity, as improper handling could compromise imaging quality or pose risks during MRI procedures.

• Which MRI field strengths is the Medrad Quad T/L Coil compatible with?

  This coil is compatible with MRI systems operating at field strengths of 1.5 Tesla (T), 1.0 Tesla (T), and 0.5 Tesla (T). The models M64TLC, M42TLC, and M21TLC are each designed to function within these specified field strengths, ensuring flexibility for different clinical MRI environments. Always verify compatibility with your specific MRI system before use.

• Is the Medrad Quad T/L Coil sterile or non-sterile?

  The Medrad Quad T/L Coil is a reusable device and is not intended to be sterile. Sterility is not a requirement for this type of passive hardware component, as it is designed for direct interfacing with MRI scanners and does not come into direct contact with patients. Proper cleaning and maintenance protocols must be followed to prevent contamination and ensure reliable performance.

• What regulatory approval does the Medrad Quad T/L Coil hold?

  The Medrad Quad T/L Coil holds FDA 510(k) clearance under the reference number K982919. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and adheres to regulatory standards for MRI coils. The device is classified under OpenFDA as a Class 2 medical device, which is the second-lowest risk category for medical devices requiring general controls and special controls.