← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K964820 # MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A (K964820) _Us Asia Instruments, Inc. · MOS · Feb 28, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K964820 ## Device Facts - **Applicant:** Us Asia Instruments, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Feb 28, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## 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. ## Regulatory 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](/device/K944469.md)) - Flexible Spine Coil ([K960497](/device/K960497.md)) - Profile 7000 C-spine Coil ([K943440](/device/K943440.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K964820 FEB 28 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS 1. Device Name: Magnetic Resonance Imaging Accessory 2. Proprietary Name: Maxim 7000 Quadrature Extremity Coil 3. Classification: Class II 4. Establishment Registration #: 1529041 5. Manufacture Facility Location: USA Instruments, Inc., 675-B Alpha Drive, Highland Heights, Ohio 44143, USA Telephone: 216-442-5920; Fax: 216-442-5919. 6. Performance Standard: No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act. 7. 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. 8. Device Description: The Quadrature Extremity Coil consists of two volume RF coil elements in a quadrature design. The elements and circuitry are enclosed in a durable covering made of vinyl naughahyde which is fire rated. please turn over 1-1 {1} 9. Safety and Effectiveness | Parameter | Quadrature Elbow Coil | Predicate | | --- | --- | --- | | | | | | Intended Use | Elbow Imaging Applications | General Purpose Flex Coil (K944469) marketed by Picker International | | Indications for Use | Identical to routine MRI imaging | General Purpose Flex Coil (K944469) marketed by Picker International | | Coil Enclosure Material | Vinyl Fabric | Flexible Spine Coil (K960497) marketed by Picker International | | Coil Design | Quadrature design | Profile 7000 C-spine Coil (K943440) marketed by US Asia Instruments. Inc. | | Decoupling | Switching Diode decoupling | Profile 7000 C-spine Coil (K943440) marketed by US Asia Instruments. Inc. | | Prevention of RF Burns | Does not transmit RF Power Decoupling isolates the coil elements from RF during RF transmission Coil elements and circuitry is enclosed in a non-conductive material. | Profile 7000 C-spine Coil (K943440) marketed by US Asia Instruments. Inc. | | Radio Frequency Absorption | Coil is a receive only coil and does not transmit RF | Profile 7000 C-spine Coil (K943440) marketed by US Asia Instruments. Inc. | | Formation of Resonant Loop | Decoupling isolates the coil elements from RF during RF transmission Length of cable and stiffness does not permit looping | Profile 7000 C-spine Coil (K943440) marketed by US Asia Instruments. Inc. | 1-2 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K964820](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K964820) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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