(73 days)
Imaging of:
- The Whole Body (including head, abdomen, breast, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels, small parts which include: wrist, elbow, ankle, shoulder, hand, knee). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
- Fluid Visualization
- 2D/3D Imaging
- MR Angiography/MR Vascular Imaging
The Flexible Small Parts coil is comprised of a flexible coil winding, tune box, and clamp. The flexible coil winding is fabricated from a single strip of copper and encased in soft closed cell foam. The winding conforms to the irregular surface of anatomy and keeps the shape it is formed to while the foam provides consistent spacing between the windings and anatomy.
Decoupling is dual active and achieved with PIN diodes. The impedance of the coil is 50 ohms nominal and it is a solenoid type coil.
The Flexible Small Parts coil is constructed with the same materials that are currently in use for the released coil set for OPART™.
This request cannot be fulfilled. The document does not contain information about acceptance criteria and device performance for the K991740 submission. It describes a medical device accessory (Flexible Small Parts coil for OPART™ MRI system) and states its intended use, but it does not include performance metrics or a study. The document is primarily a 510(k) summary and the FDA's clearance letter, which focus on substantial equivalence to a predicate device rather than detailed performance studies against specific acceptance criteria.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.