Skip to content

Magna 5000 Phased Array CTL Spine Coil

by USA Instruments, Inc. United States(FDA 510(k) applicant) 510(k)

510(k) K994345 Product code MOS

Overview

The Magna 5000 Phased Array CTL Spine Coil is a receive-only phased array RF coil designed for magnetic resonance imaging (MRI). It is classified as a specialty coil and is intended for obtaining high-resolution diagnostic images of the spine, including cervical, thoracic, and lumbar regions.

This device is supplied as a reusable component for MRI systems and is compatible with the Signa HFO/i 0.7T MRI scanner. It features a design conforming to spine contours, with a removable anterior section for cervical imaging and three bridges with coil elements for thoracic and lumbar imaging. The coil holds an FDA 510(k) clearance (K994345) and adheres to MRI safety standards for clinical use.

Summary written by AI from registry data, 19 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK994345 Date14 Feb 2000ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

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

Other devices from USA Instruments, Inc.

See all devices from USA Instruments, Inc. →

Questions

  • What is the Magna 5000 Phased Array CTL Spine Coil intended for?

    The Magna 5000 Phased Array CTL Spine Coil is a receive-only phased array RF coil designed for magnetic resonance imaging (MRI) and is intended for obtaining high-resolution diagnostic images of the spine, including cervical, thoracic, and lumbar regions.

  • Is the Magna 5000 Phased Array CTL Spine Coil reusable or single-use?

    The device is supplied as a reusable component for MRI systems, meaning it is designed for multiple uses after appropriate cleaning and disinfection between patients, not as a single-use disposable item.

  • Which MRI scanner is the Magna 5000 Phased Array CTL Spine Coil compatible with?

    The Magna 5000 Phased Array CTL Spine Coil is compatible with the Signa HFO/i 0.7T MRI scanner, as specified in the device description.

  • What regulatory pathway was used for the Magna 5000 Phased Array CTL Spine Coil?

    The device holds an FDA 510(k) clearance (K994345), indicating it was cleared through the traditional 510(k) premarket notification pathway as substantially equivalent to a legally marketed predicate device.

  • What design features does the Magna 5000 Phased Array CTL Spine Coil have for spinal imaging?

    The coil features a design conforming to spine contours, with a removable anterior section for cervical imaging and three bridges with coil elements for thoracic and lumbar imaging, allowing flexible positioning for different spinal regions.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K994345 24 fields · synced 22 Oct 2026