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Model 3100-21 Quadrature Spine Coil

by Medical Advances, Inc.

510(k) K905095

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK905095 Date11 Jan 1991ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Model 3100-21 Quadrature Spine Coil is a Nuclear Magnetic Resonance Imaging (MRI) Coil designed for spinal imaging. It enhances signal reception in MRI systems, improving the clarity and resolution of images for diagnostic evaluation of the spine, including vertebrae, intervertebral discs, and surrounding soft tissues.

This coil is intended for use in MRI environments and is supplied as a reusable accessory. It is compatible with standard MRI systems and must be handled according to manufacturer guidelines to ensure proper functionality and safety. The device is classified under the FDA’s Class II regulatory category and holds a Traditional 510(k) clearance under the Radiology advisory committee, with a decision date of January 11, 1991.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Model 3100-21 Quadrature Spine Coil in an MRI setting?

    The Model 3100-21 Quadrature Spine Coil is specifically designed to enhance signal reception during MRI scans, improving the clarity and resolution of spinal images. This includes detailed visualization of vertebrae, intervertebral discs, and surrounding soft tissues, which aids in diagnostic evaluations of spinal conditions.

  • Is the Model 3100-21 Quadrature Spine Coil intended for single-use or reusable applications?

    The Model 3100-21 Quadrature Spine Coil is supplied as a reusable accessory for MRI systems. It must be handled according to the manufacturer’s guidelines to ensure proper functionality and safety during repeated use.

  • What regulatory pathway was followed for the clearance of this MRI coil, and which committee was involved?

    The Model 3100-21 Quadrature Spine Coil received a Traditional 510(k) clearance through the FDA’s Radiology advisory committee (RA). The clearance was granted on January 11, 1991, under the classification of substantially equivalent (SESE) to a predicate device, and it falls under the FDA’s Class II regulatory category.

  • How should the Model 3100-21 Quadrature Spine Coil be stored to maintain its performance?

    While the data does not specify storage conditions explicitly, as a reusable MRI accessory, the coil should be stored in a clean, dry environment, protected from physical damage, and according to the manufacturer’s instructions to preserve its functionality and ensure compatibility with MRI systems.