RFT

Basic Information

• Brand Name: RFT
• Primary DI: 06938146600003
• Version / Model: 10-F32119
• Catalog Number: M6000CA
• Company Name: Shenzhen RF Tech Co., Ltd.
• Labeler DUNS: 530798780
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-21
• Public Version: 1
• Public Version Date: 2022-12-29
• Public Version Status: New
• Public Device Record Key: 92c56c6b-b66d-4441-bab9-d139c92fad59
• Distribution End Date: 2022-12-21

Device Description

The 8ch Wrist Coil by Shenzhen RF Tech Co., Ltd. is receive-only coil and is designed for use as general purpose coil. The 8ch Wrist Coil is designed to be use with GE 1.5T MRI systems to produce diagnostic images of the wrists and fingers that can be interpreted by a trained physician.

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
Package	16938146600000	GS1	Carton Box	1	Not in Commercial Distribution	2022-12-21
Primary	06938146600003	GS1

Premarket Submissions

Submission Number	Supplement Number
K223239	000

Device Sizes

Type	Value	Unit	Text
Width	345	Micrometer
Height	215	Millimeter
Length	412	Micrometer

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -30 – 70 Degrees Celsius