Identity
- Trade Name
- 3T 6CH Carotid Coil FDA UDI
- Generic Name
- MRI system coil, radio-frequency FDA UDI
- Device Name
- The NeoCoil 3.OT 6-Channel Carotid Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the carotid arteries and associated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its operating field strength of 3.0T, and a larger field-of-view due to the antenna layout. FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- The NeoCoil 3.OT 6-Channel Carotid Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the carotid arteries and associated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its operating field strength of 3.0T, and a larger field-of-view due to the antenna layout. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856181003015 FDA UDI
- 510(k) Number
- K070778 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
3T 6CH Carotid Coil by Neocoil, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Neocoil, Llc
Sources (1)
- FDA UDI a173e7b8-c77a-46d2-b4cb-aa6b9d851a69 34 fields · synced Jun 8, 2026