16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
Quality ElectrodynamicsThe 16ch Flex SPEEDER Medium and Large 1.5T coils are receive-only, 16-channel phased array coils designed to be used with Canon 1.5T MRI systems. These coils help produce high-quality diagnostic images of general human anatomy, assisting clinicians in accurately interpreting MRI scans for patient diagnosis.
Intended Use
Intended for use with Canon 1.5T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.
Technology
Receive-only phased array RF coil with active PIN diode switching blocking circuitry and passive blocking circuitry. Made from polycarbonate and polyurethane coated nylon fabric.
Performance
The coils were tested on a 1.5T Canon MR system with analysis of signal-to-noise ratio (SNR) and uniformity per NEMA standards. Clinical images from various body parts demonstrated diagnostic quality with no adverse events. Safety was verified with electrical, electromagnetic, biocompatibility, and surface heating tests meeting international standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/31/2024
1 month - 2
FDA Approval
2/28/2025
Other devices from Quality Electrodynamics
- SureWave Elastography (Q7000225)2025 • 510K
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