← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K963356 # PHASED ARRAY SHOULDER COIL (K963356) _Philips Medical Systems (Cleveland), Inc. · MOS · Nov 22, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K963356 ## Device Facts - **Applicant:** Philips Medical Systems (Cleveland), Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Nov 22, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The 1.5 T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Phased Array Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Shoulder and other related joint structures Nuclei Excited: Hydrogen ## Device Story Receive-only MRI coil; designed for Picker 1.5 T EDGE system. Captures hydrogen nuclei signals from shoulder and joint structures; provides improved signal-to-noise ratio (SNR), higher image resolution, and faster acquisition times compared to standard body coils. Operated by MRI technicians in clinical imaging environments. Output consists of raw RF signals processed by the host MRI system into diagnostic images. Physician interprets images to determine soft tissue structure and assist in clinical diagnosis. ## Clinical Evidence No clinical data. Substantial equivalence established via bench testing and comparison of technical specifications against the predicate device. ## Technological Characteristics Receive-only multi-channel phased array coil; hydrogen nuclei excitation; fixed tuning/impedance matching; passive diode decoupling; flame-rated thermoplastic enclosure with vinyl pads. Standalone accessory for Picker 1.5 T EDGE MRI system. ## 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 - MAI Phased Array Shoulder Coil ([K945778](/device/K945778.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} NOV 22 1996 # SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92) K963356 ## 1. General Information Classification: Class II Magnetic Resonance Imaging (MRI) Accessory Common/Usual Name: Magnetic Resonance Imaging (MRI) Coil Proprietary Name: Phased Array Shoulder Coil Establishment Registration: Picker International, Inc. World Headquarters 595 Miner Road Highland Heights, Ohio 44143 FDA Owner Number: #1580240 FDA Registration Number: #1525965 Performance Standards: Not Applicable ## 2. Intended Uses The Phased Array Shoulder Coil does not change the intended use of the Picker 1.5 T EDGE system. The 1.5 T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Phased Array Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Shoulder and other related joint structures Nuclei Excited: Hydrogen PICKER INTERNATIONAL, INC. (PASC) 8/19/96 {1} # 3. Device Description The Picker Phased Array Shoulder Coil is a receive-only coil designed to provide imaging of the shoulder and other joint structures. The coil is designed to give improved signal-to-noise ration (SNR), image resolution and image acquisition time over that of the Body Coil. # 4. Safety and Effectiveness The Picker Phased Array Shoulder Coil is substantially equivalent in safety and effectiveness to the MAI Phased Array Shoulder Coil for the GE 1.5 T Signa system. The following chart has been compiled to demonstrate the Shoulder Coil’s substantial equivalence to this device. | Parameter | Phased Array Shoulder Coil | Predicate Device MAI Phased Array Shoulder Coil (K945778) | | --- | --- | --- | | Compatible MRI Systems | Picker International 1.5 T EDGE | GE 1.5 T Signa with Phased Array Hardware Option | | Mode of Operation | Same | Receive-Only Array | | Antenna Configuration | Same | Multi-channel Array | | Tuning/Impedance Matching | Same | Fixed tuning and matching. Factory set. | | Method of Decoupling | Same | Passive diode decoupling. | | Coil Enclosure | Same | Flame rated thermoplastic enclosure and vinyl pads. | | Number of Receive Channels | Same | Four | The Phased Array Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Shoulder and other related joint structures Nuclei Excited: Hydrogen PICKER INTERNATIONAL, INC. (PASC) 8/19/96 {2} | Parameter | Phased Array Shoulder Coil | Predicate Device MAI Phased Array Shoulder Coil (K945778) | | --- | --- | --- | | Intended Use | The MAI Phased Array Shoulder Coil is indicated for use as a receive only antenna of RF energy at a specific frequency. The signal received by the coils is dependent upon MRI parameters (T1 or spin-lattice relaxation time, T2 or spin-spin relaxation time, density of nuclei, flow velocity, and chemical shift). The images produced by the imaging coil correspond to the distribution of nuclei exhibiting nuclear magnetic resonance. The MAI Phased Array Shoulder Coil is indicated for use in the following anatomic regions: shoulder and other related joint structures. The Phased Array Shoulder Coil does not change the intended use of the Picker 1.5 T EDGE system. The 1.5 T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Phased Array Shoulder Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Shoulder and other related joint structures. Nuclei Excited: Hydrogen | | PICKER INTERNATIONAL, INC. (PASC) 8/19/96 I - 3 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K963356](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K963356) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com