Device
The 1.5T GEM Flex Suite manufactured by Shenzhen RF Tech Co., Ltd. is receive-only coil and is designed for use as general-purpose coil. It includes of three coils: 16-L Array, 16-...
Manufacturer
Shenzhen RF Tech Co., Ltd.
Shenzhen RF Tech Co., Ltd.
Model: 10-F35780
Catalog: 5947081-2
DI: 06938146600171
Status: New
MRI: MR Safe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-16
Current Version: 2026-05-25
Description
The 1.5T GEM Flex Suite manufactured by Shenzhen RF Tech Co., Ltd. is receive-only coil and is designed for use as general-purpose coil. It includes of three coils: 16-L Array, 16-M Array, and 16-S Array. The 1.5T GEM Flex Suite is designed for use with GEHC 1.5T MRI systems to produce diagnostic images of the Head, Torso, Hip, Spine, Shoulder, Knee, Foot, Ankle, Elbow, and Wrist that can be interpreted by a trained physician.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b57f38bb-9e5c-476e-b8ec-d2315748c105
Distribution Status:
In Commercial Distribution
DUNS Number:
530798780
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
06938146600171
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
carton box
Item #2 - Device ID:
16938146600161
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
1
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
06938146600171
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 40749
Name: MRI system coil, radio-frequency
Definition:
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.
FDA Product Codes
MOS
Coil, Magnetic Resonance, Specialty
Premarket Submissions
Submission Number:
K252179
Supplement Number:
000