Identity
- Trade Name
- RFT EUDAMEDFDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- 1.5T HD T/R KNEE ARRAY EUDAMEDThe Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd. is transmit/receive coil and is designed for use as general purpose coil. The Knee Coil is designed to be use with GEHC 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician. FDA UDI
- Model / Reference
- 10-F34127 EUDAMEDFDA UDI5932028-2 EUDAMED
- Description
- The Knee Coil manufactured by Shenzhen RF Tech Co.,Ltd. is transmit/receive coil and is designed for use as general purpose coil. The Knee Coil is designed to be use with GEHC 1.5T MRI systems to produce diagnostic images of the knee, palm, sole, ankle, elbow, wrist that can be interpreted by a trained physician. FDA UDI
Identifiers
- Catalog Number
- 5932028-2 FDA UDI
- Primary DI / UDI-DI
- 06938146600140 EUDAMEDFDA UDI
- Basic UDI-DI
- 69381466R09K10F341HG8 EUDAMED
- 510(k) Number
- K231085 FDA UDI
- FDA Product Code
- MOS FDA UDI
- EMDN Code
- Z11020780 INTEGRATED MRI/PET SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- MRI system coil, radio-frequency FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Width — 403 Millimeter FDA UDIHeight — 325 Millimeter FDA UDIDepth — 358 Millimeter FDA UDI
Rft by Shenzhen RF Tech Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69381466R09K10F341HG8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen RF Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000010149
- Authorised Representative
- OSMUNDA Medical Technology Service GmbH DE-AR-000009285
Sources (2)
- EUDAMED 680a599e-556f-4c50-9e04-2ee9d73e670b 61 fields · synced Jul 11, 2026
- FDA UDI 3088ee6b-64e4-4c9d-9f71-5b3d7d2ee1cb 37 fields · synced May 30, 2026