Who is the manufacturer of MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY?

General Electric Co. filed the 510(k) submission for MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY (K954354).

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

Q: What are the predicate devices for MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY?

GE Shoulder Surface Coil (K892235).

K954354 · General Electric Co. · LNH · Apr 12, 1996 · Radiology

Device Facts

Record ID	K954354
Device Name	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY
Applicant	General Electric Co.
Product Code	LNH · Radiology
Decision Date	Apr 12, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended Use

The 0.2T GP Neck/Shoulder Coil expands the capability of the 0.2T MR imaging system. It accommodates and improves imaging of the cervical spine, neck, shoulder and surrounding structures.

Device Story

Receive-only, linear, circular solenoidal MRI coil; housed in biocompatible shell; includes adjustable positioning base and comfort pads. Used in clinical MRI settings by trained technologists/radiologists. Device functions as signal receiver for 0.2T MR imaging systems to improve image quality of cervical spine, neck, and shoulder anatomy. Output is raw MR signal processed by host system into diagnostic images for physician interpretation. Benefits include enhanced anatomical visualization for clinical decision-making.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Receive-only, linear, circular solenoidal coil; biocompatible outer shell; includes adjustable positioning base and comfort pads. Designed for 0.2T MR imaging systems.

Indications for Use

Indicated for patients requiring MRI imaging of the cervical spine, neck, shoulder, and surrounding structures using a 0.2T MR imaging system.

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

GE Shoulder Surface Coil (K892235)

Related Devices

K041921 — GE SIGNA PROFILE 6 INCH GP COIL · Ge Medical Systems, LLC · Jul 26, 2004
K981959 — OUTLOOK LARGE PHASED ARRAY NECK COIL · Philips Medical Systems (Cleveland), Inc. · Jul 31, 1998
K052077 — G-SCAN CERVICAL SPINE COIL · Esaote, S.p.A. · Aug 16, 2005
K984257 — MEDRAD PHASED ARRAY NEUROVASCULAR COIL · Medrad, Inc. · Jan 25, 1999
K982959 — MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC · Medrad, Inc. · Nov 3, 1998

Submission Summary (Full Text)

{0} K954354 GE Medical Systems General Electric Company PO Box 414, Milwaukee, WI 53201 APR 12 1996 0.2T GP Neck/Shoulder Coil September 14, 1995 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 Phone: 414-544-3894 Fax: 414-544-3863 Product: 0.2T GP Neck/Shoulder Coil Manufactured by GE Yokogawa Medical System, Ltd. Tokyo, Japan 1) Indications for Use The 0.2T GP Neck/Shoulder Coil expands the capability of the 0.2T MR imaging system. It accommodates and improves imaging of the cervical spine, neck, shoulder and surrounding structures. 2) Device Description The 0.2T GP Neck/Shoulder Coil is a receive-only, linear, circular solenoidal coil contained in a biocompatible outer shell. The coil comes with an adjustable positioning base and comfort pads for support. 3) Marketing History The 0.2T GP Neck/Shoulder Coil has not been previously marketed by GE Medical Systems. 4) Potential Adverse Effects on Health The use of the 0.2T GP Neck/Shoulder Coil does not result in any additional potential hazards compared to previously marketed receive-only surface coils. 5) Conclusions It is the opinion of GE Medical Systems that the 0.2T GP Neck/Shoulder Coil is substantially equivalent to the presently marketed GE Shoulder Surface Coil (#K892235).