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Premier III Phased Array CTL Spine Coil

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

510(k) K030042 Product code MOS

Overview

The Premier III Phased Array CTL Spine Coil is a Magnetic Resonance, Specialty Coil designed for high-resolution imaging of the cervical, thoracic, and lumbar spine regions. As a receive-only phased array RF coil, it enhances signal sensitivity and spatial resolution, improving diagnostic clarity in MRI systems.

This device is intended for use with compatible MRI systems, including those from Siemens and Philips, and is classified as a Class II medical device under FDA regulations. It is supplied as a reusable component, requiring proper cleaning and maintenance per manufacturer guidelines. The coil is not MRI-conditional but must be used within the specified magnetic field strength of the associated MRI system.

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 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030042 Date24 Feb 2003ClearedStatusActive

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

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Questions

  • What MRI systems is the Premier III Phased Array CTL Spine Coil compatible with, and how does it improve imaging quality?

    The Premier III Phased Array CTL Spine Coil is designed for use with compatible MRI systems from Siemens and Philips. As a receive-only phased array RF coil, it enhances signal sensitivity and spatial resolution, which improves diagnostic clarity for high-resolution imaging of the cervical, thoracic, and lumbar spine regions.

  • Is the Premier III Phased Array CTL Spine Coil intended for single-use or reusable applications, and what maintenance is required?

    The Premier III Phased Array CTL Spine Coil is supplied as a reusable component. Proper cleaning and maintenance are required per the manufacturer’s guidelines to ensure optimal performance and longevity.

  • What magnetic field strength range should the MRI system using this coil operate within?

    The Premier III Phased Array CTL Spine Coil is not MRI-conditional, meaning it must be used within the specific magnetic field strength range of the associated MRI system. While the exact range isn’t specified, it is designed to function reliably with compatible MRI systems from Siemens and Philips.

  • How was the regulatory pathway for this device determined, and what type of review was conducted?

    The Premier III Phased Array CTL Spine Coil was determined to be substantially equivalent to a legally marketed predicate device, allowing it to follow the traditional 510(k) clearance pathway. The review was conducted by the FDA’s Radiology (RA) Advisory Committee, and the decision was made under the classification of a Class II medical device.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K030042 24 fields · synced 22 Oct 2026