Carotid Coil GE 1.5T
by Tursiop Technologies, LLC 510(k)
Active
510(k) K113280
Overview
The Carotid Coil GE 1.5T is a receive-only 2-channel diagnostic magnetic resonance imaging coil designed for use in radiology. It is classified as a Coil, Magnetic Resonance, Specialty (product code MOS) and is intended for high-resolution imaging of the carotid arteries at a static magnetic field strength of 1.5 Tesla. This coil enhances signal detection for vascular structures, aiding in the assessment of carotid stenosis or other pathologies.
This device is supplied as a single-use or reusable component, depending on manufacturer guidelines, and is compatible with 1.5T MRI systems (e.g., GE Twinspeed). It is regulated under FDA 510(k) clearance (K113280) and falls under Class II special controls for magnetic resonance coils. Storage and handling must adhere to MRI safety protocols to prevent interference or damage. No explicit sterility requirements are noted in the regulatory data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113280 | Date23 Nov 2011 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MOS
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Tursiop Technologies, LLC
Questions
What is the Carotid Coil GE 1.5T used for?
The Carotid Coil GE 1.5T is a receive-only 2-channel diagnostic magnetic resonance imaging coil designed specifically for high-resolution imaging of the carotid arteries. It improves signal detection for vascular structures, aiding in the assessment of carotid stenosis or other pathologies. This coil is optimized for use in radiology settings where detailed visualization of the carotid arteries is critical.
Is the Carotid Coil GE 1.5T single-use or reusable?
The Carotid Coil GE 1.5T can be supplied as either single-use or reusable, depending on the manufacturer’s guidelines. While the coil itself is not explicitly labeled as sterile, its use and handling must follow MRI safety protocols to prevent interference or damage. Reusability is typically determined by the facility’s infection control policies and the coil’s condition after use.
Which MRI systems is the Carotid Coil GE 1.5T compatible with?
The Carotid Coil GE 1.5T is designed for compatibility with 1.5 Tesla MRI systems, specifically systems like the GE Twinspeed. It is engineered to enhance imaging performance within this magnetic field strength, ensuring optimal visualization of carotid arteries for diagnostic purposes.
What storage and handling precautions should be taken for the Carotid Coil GE 1.5T?
Storage and handling of the Carotid Coil GE 1.5T must strictly adhere to MRI safety protocols to avoid interference or damage. This includes proper shielding from external magnetic fields, avoiding physical stress, and following manufacturer guidelines for cleaning and maintenance if reused. Facilities should ensure the coil is stored in a controlled environment to preserve its performance and integrity.
What regulatory pathway does the Carotid Coil GE 1.5T follow?
The Carotid Coil GE 1.5T is regulated under the FDA 510(k) clearance pathway, with a clearance number of K113280. It is classified as a Class II device under special controls for magnetic resonance coils and falls under the product code MOS (Coil, Magnetic Resonance, Specialty). The device was reviewed by the Radiology Devices Panel of the Radiological Devices Advisory Committee.