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Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil

FDA 510(k)

Class II (US FDA 510(k))

510(k) K982772

by Ge Medical Systems, Inc.

Identifiers

510(k) Number
K982772 FDA 510(k)
FDA Product Code
MOS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a receive-only magnetic resonance (MR) coil, classified as a specialty coil for thoracic and lumbar spine imaging. It is designed to enhance signal reception in MRI systems with vertical magnetic fields, improving image quality for spinal evaluations. The phased array configuration optimizes coverage and resolution for diagnostic imaging of the thoracic and lumbar regions. Its design aligns with the Coil, Magnetic Resonance, Specialty nomenclature under FDA product code MOS.

The coil is intended for use in MRI environments and is supplied as a reusable component for clinical diagnostic imaging. It is not sterile and requires proper handling and cleaning per manufacturer guidelines. Compatible with vertical-field MRI systems, it adheres to MRI safety standards for use in radiology settings. Authorized under FDA 510(k) clearance (K982772), it falls under Class II regulatory classification with special controls. No third-party review was involved in its submission.

Frequently asked questions

What is the SIGNA Profile Quad Thoracic/Lumbar Spine Phased Array Coil used for?

This device is a receive-only magnetic resonance (MR) coil designed specifically for thoracic and lumbar spine imaging. Its phased array configuration improves signal reception and image resolution, making it ideal for detailed diagnostic evaluations of the spine in MRI environments with vertical magnetic fields.

Is the SIGNA Profile Quad Thoracic/Lumbar Spine Phased Array Coil reusable or single-use?

The SIGNA Profile Quad Thoracic/Lumbar Spine Phased Array Coil is supplied as a reusable component. It is intended for repeated use in clinical settings, provided it is properly cleaned and maintained according to manufacturer guidelines.

Does the SIGNA Profile Quad Thoracic/Lumbar Spine Phased Array Coil come sterile?

No, the SIGNA Profile Quad Thoracic/Lumbar Spine Phased Array Coil is not sterile. It is designed for use in MRI environments where proper handling and cleaning procedures are followed to ensure safety and functionality.

Which MRI systems is the SIGNA Profile Quad Thoracic/Lumbar Spine Phased Array Coil compatible with?

This coil is designed for compatibility with MRI systems that utilize vertical magnetic fields. It adheres to MRI safety standards and is intended for use in radiology settings where such systems are employed.

What regulatory pathway was followed for the SIGNA Profile Quad Thoracic/Lumbar Spine Phased Array Coil?

The SIGNA Profile Quad Thoracic/Lumbar Spine Phased Array Coil was authorized under the FDA 510(k) clearance process, specifically under the Traditional clearance type. It was determined to be substantially equivalent to a legally marketed device and falls under Class II regulatory classification with special controls.

This description and any FAQs above were generated automatically from registry data 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. Sources consulted: Signa Profile Quadrature Thoracic/Lumbar Spine Phased Array Coil, K982772 FDA 510(k) - SIGNA PROFILE QUADRATURE THORACIC/LUMBA..., SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL 510 (k ..., K982772 FDA 510(k) - SIGNA PROFILE QUADRATURE THORACIC/LUMBA...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ge Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K982772 24 fields · synced Oct 5, 2026