Identity
- Trade Name
- Y-Cable Top/Bottom Array 3T SI FDA UDI
- Generic Name
- Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal FDA UDI
- Model / Reference
- 02 FDA UDI
Identifiers
- Catalog Number
- 815053 FDA UDI
- Primary DI / UDI-DI
- 04251269203749 FDA UDI
- 510(k) Number
- K091546 FDA UDI
- FDA Product Code
- MOS FDA UDI
- GMDN Term
- Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Tumour-therapy radio-frequency hyperthermia system applicator, intracorporeal
Y-Cable Top/Bottom Array 3T SI by NORAS MRI products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K091546 also covers:
- Cable Top/Bottom Array 3T SI — NORAS MRI products GmbH
- NORAS OR HEAD COIL BOTTOM ARRAY SIEMENS 3T — NORAS MRI products GmbH
- NORAS OR HEAD COIL Bottom Array Siemens 3T — NORAS MRI products GmbH
- NORAS OR HEAD COIL Bottom Array Siemens 3T — NORAS MRI products GmbH
- NORAS OR HEAD COIL Bottom Array Siemens 3T Refurbished — NORAS MRI products GmbH
- NORAS OR HEAD COIL Top Array Siemens 3T — NORAS MRI products GmbH
- NORAS OR HEAD COIL Top Array Siemens 3T — NORAS MRI products GmbH
- NORAS OR HEAD COIL Top Array Siemens 3T — NORAS MRI products GmbH
- NORAS OR HEAD COIL Top Array Siemens 3T — NORAS MRI products GmbH
- NORAS OR HEAD COIL Top Array Siemens 3T Refurbished — NORAS MRI products GmbH
- NORAS OR HEADCOIL Bottom Array Siemens 3T Refurbished — NORAS MRI products GmbH
- NORAS OR HEADCOIL Bottom Array Siemens 3T Refurbished — NORAS MRI products GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- NORAS MRI products GmbH
Sources (1)
- FDA UDI fd48ccb5-3f59-4b6f-a21d-0582bcf9b4f5 35 fields · synced Jun 8, 2026