Qquadrature Lumbar Contour Coil

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

510(k) Number

K922006 ↗

FDA Product Code

LNH

Device Class

Class II

Regulation

21 CFR Part 892.1000

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Quadrature Cervical Contour Coil

  Class II

  FDA 510(k) K923881 Active Cleared 5 Nov 1992

• Anterior Neck Contour Coil

  Class II

  FDA 510(k) K905512 Active Cleared 7 Mar 1991

• Bilateral Temporal Mandibular Joint Coil

  Class II

  FDA 510(k) K930991 Active Cleared 18 Jun 1993

• Telerad Stat

  Class I

  FDA 510(k) K931795 Active Cleared 19 Nov 1993

• Quadrature Shoulder Contour Coil

  Class II

  FDA 510(k) K920227 Active Cleared 24 Aug 1992

• Phased Array/Bilateral Quadrature Contour Coil

  Class II

  FDA 510(k) K932091 Active Cleared 14 Dec 1993

See all devices from Magnetic Research, Inc. →

• What is the primary purpose of the Quadrature Lumbar Contour Coil in MRI imaging?

  The Quadrature Lumbar Contour Coil is specifically designed to enhance signal quality and spatial resolution during MRI scans of the lumbar spine. By improving these parameters, it helps radiologists achieve more accurate diagnostic imaging for identifying spinal pathologies, such as herniated discs, degenerative changes, or other abnormalities in the lower back region.

• Is this coil intended for single-use or can it be reused in clinical settings?

  The Quadrature Lumbar Contour Coil is supplied as a reusable component for MRI systems. Since it is not sterile, it must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and safety in radiology settings.

• How is the coil compatible with MRI systems, and are there any special handling requirements?

  The coil is MRI-safe and designed for use in standard MRI environments, meaning it does not interfere with the magnetic field or pose risks during imaging. However, because it is non-sterile, it requires proper cleaning and maintenance per manufacturer instructions to prevent contamination and ensure reliable performance over repeated use.

• What regulatory pathway was followed for this device’s approval, and what class does it fall under?

  The Quadrature Lumbar Contour Coil is classified as a Class II device under FDA regulations and was cleared through a Traditional 510(k) pathway (K922006). The submission was reviewed by the FDA’s Radiology (RA) Advisory Committee, with a decision date of July 29, 1992, confirming it as substantially equivalent to predicate devices.