Who is the manufacturer of MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY?

General Electric Co. filed the 510(k) submission for MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K964306).

What is the FDA product code for MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY

K964306 · General Electric Co. · LNH · Jan 17, 1997 · Radiology

Device Facts

Record ID	K964306
Device Name	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
Applicant	General Electric Co.
Product Code	LNH · Radiology
Decision Date	Jan 17, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

The Signa SP Flexible Coil family provides imaging capability for the Signa SP MR System by facilitating magnetic resonance imaging of irregular anatomy and providing a mechanism for static or dynamic (i.e., flexion of joints or the spine) dynamic magnetic resonance imaging.

Device Story

Signa SP Flex Coils; symmetric transmit/receive surface coils; helmholtz pair configuration; flexible, biocompatible outer covering. Used with Signa SP MR System; facilitates imaging of irregular anatomy; enables static or dynamic (joint/spine flexion) MRI. Operated by MRI technicians/radiologists in clinical imaging environments. Output: MR image data for diagnostic interpretation by physicians. Benefit: improved imaging of non-planar anatomy and dynamic joint movement.

Clinical Evidence

Bench testing only.

Technological Characteristics

Symmetric transmit/receive surface coils; helmholtz pair configuration; flexible biocompatible outer covering; dimensions vary by model; passive RF coil technology.

Indications for Use

Indicated for patients requiring magnetic resonance imaging of irregular anatomy or joints/spine, including static or dynamic imaging applications.

Regulatory Classification

Identification

A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

Special Controls

*Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

Signa SP MR System (K942604)

Related Devices

K964969 — SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) · GE Medical Systems · Jun 26, 1997
K030953 — GE 3.0T GENERAL PURPOSE FLEX COIL · Ge Medical Systems, Inc. · Apr 10, 2003
K193140 — Flex Body SPEEDER · Quality Electrodynamics, LLC · Jan 3, 2020
K182590 — 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA · GE Healthcare · Oct 19, 2018
K093842 — 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS · Invivo Corporation · Mar 5, 2010

Submission Summary (Full Text)

{0} JAN 17 1997 GE Medical Systems General Electric Company P.O. Box 454, Milwaukee, WI 53201 K964306 # Signa SP Flex Coils October 28, 1996 General Electric Medical Systems ## SUMMARY OF INFORMATION REGARDING SAFETY AND EFFECTIVENESS This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h). Contact: Larry A. Kroger, Ph.D. Phone: 414-544-3894 FAX: 414-544-3863 Product: Signa SP Flex Coils Manufactured by General Electric Medical Systems Waukesha, Wisconsin, USA 1) Indications for Use The Signa SP Flexible Coil family provides imaging capability for the Signa SP MR System by facilitating magnetic resonance imaging of irregular anatomy and providing a mechanism for static or dynamic (i.e., flexion of joints or the spine) dynamic magnetic resonance imaging. 2) Device Description The Signa SP Flex Coils are a group of symmetric transmit/receive surface coils of varying dimensions that are coupled as helmholtz pairs and contained in a flexible, biocompatible outer covering. 3) Marketing History The Signa SP Flex Coils have not been previously marketed by GE Medical Systems. 4) Potential Adverse Effects on Health The use of the Signa SP Flex Coils does not result in any additional potential hazards compared to previously marketed flexible transmit/receive surface coils. 5) Conclusions It is the opinion of GE Medical Systems that the Signa SP Flex Coils are substantially equivalent to the presently marketed transmit/receive flexible surface coil contained in the Signa SP MR System (K942604).