Identity
- Trade Name
- NORAS OR HEAD COIL BOTTOM ARRAY SIEMENS 3T FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Model / Reference
- 03 FDA UDI
Identifiers
- Catalog Number
- 113719 FDA UDI
- Primary DI / UDI-DI
- 04251269202612 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
MR Safe FDA UDI
Category: MRI system coil, radio-frequency
Noras Or Head Coil Bottom Array Siemens 3t by NORAS MRI products GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as MRI system coil, radio-frequency.
- Dunlee Sentinelle — Philips Medical Systems Nederland B.V. · Class II
- 16Ch Flex SPEEDER Pad Kit — NEOCOIL, LLC · Class II
- ScanMed Long Bone (L) Coil — SCANMED, LLC · Class II
- ScanMed Elbow Coil — SCANMED, LLC · Class II
- Invivo — Philips DS North America LLC · Class II
- TMJ COIL — Esaote S.p.A. · Class I
- dS Flex Coil M 1.5T — Philips Healthcare (Suzhou) Co., Ltd. · Class IIb
- Atlas SPEEDER Head-Neck Coil — QUALITY ELECTRODYNAMICS LLC · Class II
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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NORAS MRI products GmbH
Sources (1)
- FDA UDI 267eceac-e6aa-41c0-ac07-d85b681cabfc 35 fields · synced May 31, 2026