FDA.reportPublic FDA data

RFT

Primary DI
06938146600249
Brand
RFT
Company
Shenzhen RF Tech Co., Ltd.
Model
10-F34742
Catalog number
5941776-3
Device description
The 3.0T GEM Flex Suite manufactured by Shenzhen RF Tech Co., Ltd. is receive-only coil and is designed for use as general-purpose coil. It include of three coils: 16-L Array, 16-M Array, and 16-S Array. The 3.0T GEM Flex Suite is designed for use with GEHC 3.0T 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.
Published
2026-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252876000GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.2026-04-01MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16938146600239PackageGS11In Commercial Distribution
06938146600249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693814660023916938146600239
06938146600249069381466002496938146600249

Regulatory Flags#

DUNS number
530798780
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938146600171RFT10-F357805947081-22026-05-16
06938146600188RFT10-F357815947081-32026-05-09
06938146600195RFT10-F357825947081-42026-05-09
06938146600225RFT10-F347225939668-22026-05-09
06938146600232RFT10-F347445941776-22026-05-09
06938146600256RFT10-F347435941776-42026-05-09
06938146600003RFT10-F32119M6000CA2022-12-21
06938146600027RFT10-F23936M7001NM2016-08-03
06938146600034RFT10-F24260M7006PB2017-12-13
06938146600041RFT10-F24261M7006PC2017-12-13
06938146600058RFT10-F24262M7006PD2017-12-13
06938146600072RFT10-F25062M7006PF2020-08-11
06938146600089RFT10-F25063M7006PG2020-08-11
06938146600140RFT10-F341275932028-22023-10-09
16938146600000RFT10-F32119M6000CA2022-12-21
06938146600102RFT10-F318965869241-22023-04-08
06938146600119RFT10-F2880858808672023-04-08
06938146600065RFT10-F25061M7006PE2020-08-11
06938146600010RFT10-F21457M7001KM2016-03-30
16938146600130RFT10-F341275932028-22023-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
001989531114373.0T AIR 32CH HNAUSA INSTRUMENTS, INC.MOS2026-11-02
00850042098172MRI Receive Coil (Receive Only)Promaxo LLCMOS2026-10-19
00850042098196Fiducial CoilPromaxo LLCMOS2026-10-19
00198953007716NAGE Medical Systems, L.L.C.MOS2026-10-07
001989530665533.0T AIR PA XLUSA INSTRUMENTS, INC.MOS2026-10-07
00884838111622Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838112667Smart Fit Knee 3.0TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838131866Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838133235dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838133242dS MSK S 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00195278925282NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDMOS2026-05-11
04260486610339NBAC 3.0T PH I FlexLMT Medical Systems GmbHMOS2026-04-28
04260486610605NBAC 1.5T GE P SpineLMT Medical Systems GmbHMOS2026-04-28
00814848020836Contour Hand Wrist 0.55TQUALITY ELECTRODYNAMICS LLCMOS2026-04-23
00850083516000Nuzzle Body Array, 1.5TInkspace Imaging, Inc.MOS2026-04-21
00850083516017Silhouette Body Array – PH 3T (Cherry Blossoms)Inkspace Imaging, Inc.MOS2026-04-21
00860008041371Snuggle Pediatric Array – PH 3T (Dino)Inkspace Imaging, Inc.MOS2026-04-21
00860008041395Nuzzle Body Array – PH 3T (Whimsical)Inkspace Imaging, Inc.MOS2026-04-21
00884838130548DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130555DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130562DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130579DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130586DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130593DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130609DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130616DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130623DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132597DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132603DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838093089MRI CoilsPhilips Ds North America LLCMOS2025-10-01