Neocoil 3.0T 6-CHANNEL Carotid Array Coil
FDA 510(k)Class II (US FDA 510(k))
by Neocoil
Identifiers
- 510(k) Number
- K070778 FDA 510(k)
- FDA Product Code
- MOS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1000 FDA 510(k)
- Regulation Number
- 892.1000 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Neocoil 3.0T 6-Channel Carotid Array Coil is a receive-only phased array radiofrequency (RF) coil designed for high-resolution magnetic resonance imaging (MRI) of carotid arteries and associated vasculature. Classified as a specialty MRI coil, it is intended for imaging from the sternal notch through the internal carotid arteries at the level of cervical vertebra C1, enhancing signal-to-noise ratio (SNR) for diagnostic clarity.
This device is supplied as a reusable, non-sterile component for use in MRI systems operating at 3.0 Tesla. It consists of two foam-covered paddles, each containing three antennas, secured by a headband with a ball-and-socket joint for adjustable patient positioning. The coil is FDA-cleared under 510(k) K070778 as substantially equivalent to predicate devices, adhering to Class II regulatory standards (892.1000). No MRI safety certifications beyond standard coil compatibility are specified.
Frequently asked questions
What is the Neocoil 3.0T 6-Channel Carotid Array Coil used for?
This device is designed specifically for high-resolution magnetic resonance imaging (MRI) of carotid arteries and associated vasculature. It enhances diagnostic clarity by improving the signal-to-noise ratio (SNR) in MRI scans, allowing for detailed visualization from the sternal notch through the internal carotid arteries at the level of cervical vertebra C1. This is particularly useful for radiologists assessing vascular conditions.
How is the Neocoil 3.0T 6-Channel Carotid Array Coil supplied and what does it include?
The coil is supplied as a reusable, non-sterile component. It consists of two foam-covered paddles, each containing three antennas, connected via a headband with a ball-and-socket joint. This design allows for adjustable positioning to fit different patient anatomies, ensuring optimal imaging alignment.
Is the Neocoil 3.0T 6-Channel Carotid Array Coil sterile?
No, the coil is not sterile and is intended for reusable use in MRI systems operating at 3.0 Tesla. Since it is non-sterile, it must be cleaned and maintained according to standard MRI coil protocols to ensure hygiene and functionality between uses.
Can this coil be used with any 3.0 Tesla MRI system?
The coil is designed for use with 3.0 Tesla MRI systems, but compatibility may depend on the specific system’s technical specifications and the manufacturer’s guidelines. While it is FDA-cleared for general use in MRI systems at this field strength, users should verify compatibility with their particular equipment to ensure proper operation and safety.
What regulatory approval does the Neocoil 3.0T 6-Channel Carotid Array Coil hold?
The coil holds FDA 510(k) clearance under the reference number K070778, classified as substantially equivalent to predicate devices. It adheres to Class II regulatory standards under the regulation number 892.1000. This clearance indicates that the device meets the necessary safety and performance requirements for its intended use in MRI imaging.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL - fda.innolitics.com, NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL by NEOCOIL | FDA 510 (k) Summary, Neocoil 3.0T 6-Channel Carotid Array Coil | allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070778 | Class II | Active |
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Manufacturer
- Manufacturer
- Neocoil
Sources (1)
- FDA 510(k) K070778 24 fields · synced Oct 1, 2026