FDA.reportPublic FDA data

RFT

Primary DI
06938146600089
Brand
RFT
Company
Shenzhen RF Tech Co., Ltd.
Model
10-F25063
Catalog number
M7006PG
Device description
8ch Flex 40 Array
Published
2020-08-11
Public version status
Update
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
K200836000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2008360008ch Flex SuiteShenzhen RF Tech Co., Ltd.2020-07-22MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16938146600086PackageGS11In Commercial Distribution
06938146600089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693814660008616938146600086
06938146600089069381466000896938146600089

Regulatory Flags#

DUNS number
530798780
Device count
1
Serial number
true
Manufacturing date on label
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
06938146600249RFT10-F347425941776-32026-05-09
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
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