MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
Device Facts
| Record ID | K964820 |
|---|---|
| Device Name | MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A |
| Applicant | Us Asia Instruments, Inc. |
| Product Code | MOS · Radiology |
| Decision Date | Feb 28, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1000 |
| Device Class | Class 2 |
Intended Use
The Quadrature Extremity Coil is a receive-only quadrature RF coil, used for obtaining diagnostic images of the elbow anatomy in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Quadrature Extremity Coil is designed for use with GE Signa (1.5 Tesla) MRI scanner manufactured by GE Medical Systems.
Device Story
Receive-only quadrature RF coil; inputs radio frequency signals from elbow anatomy during MRI scanning; transforms signals into diagnostic images via GE Signa (1.5T) MRI scanner; used in clinical imaging environments by trained MRI technologists/radiologists; output viewed by clinicians to assess elbow pathology; benefits include improved image quality for diagnostic decision-making.
Clinical Evidence
Bench testing only; no clinical data provided. Safety and effectiveness established through comparison of design, materials, and operational parameters with predicate devices.
Technological Characteristics
Receive-only quadrature RF coil; two volume RF coil elements; vinyl naughahyde fire-rated enclosure; switching diode decoupling; non-transmit design; compatible with GE Signa 1.5T MRI systems.
Indications for Use
Indicated for patients requiring diagnostic MRI imaging of the elbow anatomy, consistent with standard MR imaging indications.
Regulatory Classification
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).
Special Controls
*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.
Predicate Devices
- General Purpose Flex Coil (K944469)
- Flexible Spine Coil (K960497)
- Profile 7000 C-spine Coil (K943440)
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- K963356 — PHASED ARRAY SHOULDER COIL · Philips Medical Systems (Cleveland), Inc. · Nov 22, 1996
- K964854 — MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL · Medrad, Inc. · Feb 11, 1997
- K162029 — 16ch T/R Knee Coil · Quality Electrodynamics, LLC · Oct 18, 2016
