Identity
- Trade Name
- NORAS OR HEAD COIL Bottom Array Siemens 3T FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- The intended use of the NORAS OR head coil, is in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging). FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- The intended use of the NORAS OR head coil, is in conjunction with a Magnetic Resonance Scanner, the MR examination of the human brain just before, during and at the end of the brain surgery in the operating room. The coil can also be used as a standard diagnostic head coil for diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging). FDA UDI
Identifiers
- Catalog Number
- 113719 FDA UDI
- Primary DI / UDI-DI
- 04251269206283 FDA UDI
- 510(k) Number
- K091546 FDA UDI
- FDA Product Code
- MOS FDA UDI
- GMDN Term
- MRI system coil, radio-frequency 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
Category: MRI system coil, radio-frequency
NORAS OR HEAD COIL Bottom Array Siemens 3T by NORAS MRI products GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 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
- NORAS OR HEADCOIL Bottom Array Siemens 3T Refurbished — NORAS MRI products GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- NORAS MRI products GmbH
Sources (2)
- FDA UDI 9334e31d-15c6-4c12-aa9c-a301f955cdc5 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026