3T 32Ch Torso Coil - Posterior

Basic Information

• Brand Name: 3T 32Ch Torso Coil - Posterior
• Primary DI: 00856181003039
• Version / Model: 03
• Company Name: NEOCOIL, LLC
• Labeler DUNS: 781155176
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-16
• Public Version: 4
• Public Version Date: 2020-03-05
• Public Version Status: Update
• Public Device Record Key: 4ad67684-aa4c-4021-a3b8-889066eb5440

Device Description

The NeoCoil 3.OT 32-Channel Torso Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the chest, abdomen, and pelvic area in Magnetic Resonance Imaging Systems. The coil consists of 2 antenna arrays; a posterior and an anterior. The posterior array contains 17 elements to achieve 16 channels and is enclosed in a rigid housing. The anterior array also contains 17 elements to achieve the later 16 channels but is enclosed in a flexible housing. The coil is wrapped around the patient's torso with hook and loop straps. The NeoCoil 3.0T 32-Channel Torso Array Coil is for use with the GE S.OT HD Series MR System (K052293)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOS	Coil, Magnetic Resonance, Specialty	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40749	MRI system coil, radio-frequency	A radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856181003039	GS1

Premarket Submissions

Submission Number	Supplement Number
K073236	000