Interventional Body Coil
by USA Instruments, Inc. United States 510(k)
510(k) K000437
Product code MOS
Overview
The Interventional Body Coil is a Magnetic Resonance, Specialty device designed for use in MRI systems to enhance imaging of internal body structures during interventional procedures. It functions as a coil assembly that improves signal reception and resolution, facilitating real-time visualization of vascular and soft tissue anatomy for diagnostic and therapeutic interventions.
This device is supplied as a reusable component for MRI systems and is intended for use in radiology settings. It is not sterile and requires proper cleaning and maintenance between procedures. The coil is classified under § 892.1000 and has received FDA 510K clearance as substantially equivalent to a predicate device. Multiple FEI numbers (e.g., 3009529630, 3027339477) and registration numbers (e.g., 1058584) are associated with its regulatory submission.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000437 | Date14 Apr 2000 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
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 USA Instruments, Inc.
Questions
What is the Interventional Body Coil used for?
The Interventional Body Coil is a specialty MRI device designed to improve signal reception and resolution during interventional procedures. It enhances real-time visualization of internal body structures, including vascular and soft tissue anatomy, which aids clinicians in diagnostic and therapeutic interventions. This is particularly useful in radiology settings where precise imaging is critical for guiding procedures like biopsies or vascular interventions.
Is the Interventional Body Coil sterile and single-use?
No, the Interventional Body Coil is not sterile and is intended for reusable use. It is supplied as a component for MRI systems and requires proper cleaning and maintenance between procedures to ensure optimal performance and prevent contamination. Always follow manufacturer guidelines for cleaning and sterilization protocols.
How is the Interventional Body Coil supplied and where is it used?
The Interventional Body Coil is supplied as a reusable component specifically designed for integration with MRI systems. It is intended exclusively for use in radiology settings where interventional MRI procedures are performed. The coil is not sterile and must be cleaned and maintained according to the manufacturer’s instructions to ensure safe and effective operation.
What regulatory approval does the Interventional Body Coil hold?
The Interventional Body Coil has received FDA 510K clearance, demonstrating that it is substantially equivalent to a predicate device. This clearance is based on a review by the FDA’s Radiology (RA) Advisory Committee and falls under the product code MOS. The device is classified under § 892.1000 and is intended for use in MRI systems to improve imaging quality during interventional procedures.
What should be considered for storage and maintenance of the Interventional Body Coil?
Since the Interventional Body Coil is reusable, it must be stored in a clean, dry environment to prevent damage or contamination. After each use, follow the manufacturer’s instructions for thorough cleaning and maintenance to ensure proper functionality. Proper storage and care are essential to extend the coil’s lifespan and maintain its performance for accurate MRI imaging during interventional procedures.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K000437