← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K961391 # FLEXART QD HEAD/NECK COIL (K961391) _Toshiba America Mri, Inc. · MOS · Jul 9, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K961391 ## Device Facts - **Applicant:** Toshiba America Mri, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Jul 9, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use General disease and vascular imaging of the head and cervical regions ## Device Story Flexart Head and Neck Coil (MRT-50GP) is a quadrature (QD) receive-only MRI coil accessory; extension of standard cervical collar. Input: RF signals from patient anatomy. Operation: two independent RF loops (rectangular and figure-8) oriented at 90 degrees; impedance matching via varactors; signal amplification via low-noise amplifiers. Active decoupling during transmit via high-impedance parallel resonant traps activated by diodes. Output: RF signals for MRI image reconstruction. Used in clinical MRI suites; operated by MRI technicians/radiologists. Enhances image signal-to-noise ratio for head and cervical region diagnostics. ## Clinical Evidence Bench testing only. Performance metrics provided include signal-to-noise ratio (SNR) for transaxial (73.2), coronal (62.3), and sagittal (61.2) planes within a 10 cm dsv volume. Safety parameters (static field strength 0.5T, RF power deposition 0.256 W/kg) verified against predicate. ## Technological Characteristics Receive-only QD head and neck coil. Materials: printed circuit coil trace board. Sensing: two independent RF loops (rectangular and figure-8) in quadrature. Impedance matching: varactors. Decoupling: high-impedance parallel resonant traps with diodes. Energy: RF magnetic field. Connectivity: standalone MRI accessory. ## 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 - Flexart system and standard QD C-Spine Coil ([K933018](/device/K933018.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} 9 1996 510(k) Summary K961391 Date: 8 April 1996 Submitter: Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080 Contact: Steven M. Kay (714) 730-5000 Classification Name: Magnetic Resonance Device Accessory - QD Head and Neck Coil Classification: Class II-90LNH, per 21 CFR 892.1000 Common Name: Head and Neck Coil Proprietary Name: Flexart Head and Neck Coil Model Name: MRT-50GP Establishment Registration Number: 2936923 ## Applicable Performance Standards: None, although this device follows the requirements of the current Guidance for the Content and Review of a Magnetic Resonance Diagnostic Device 510(k) Application. ## Substantial Equivalence Summary: The Flexart™ Head and Neck Coil is essentially a QD (quadrature) extension of the standard receive only Cervical Collar cleared with the Flexart. The extension consists of adding a figure-8 planar loop onto the printed circuit coil trace board, so that there are now two independent RF loops (one rectangular and one figure-8). The RF magnetic fields from the two loops are oriented at 90 degrees with respect to each other (in quadrature). The two loops are matched in impedance and tuned to the imaging system's center frequency by using varactors and the RF outputs are then amplified with low noise amplifiers. The active decoupling of the coil during transmit is achieved by use of two (one for each loop) high impedance parallel resonant traps which are activated by diodes. These diodes turn on because of the inductively coupled voltage from the transmitter coil's RF magnetic field. The Flexart Head and Neck Coil does not change the previously cleared safety parameters of the Flexart system and standard QD C-Spine Coil. Manufacturing methods and software verification and validation procedures for the Flexart system and standard QD C-Spine Coil remain unchanged. AI {1} # Safety Parameters | Maximum Static Field Strength | 0.5Tesla | | --- | --- | | Rate of Change of Magnet Field: | 6.97 T/s axial, 10.64 T/s transverse, with T>700 microseconds | | Radiofrequency Power Deposition: | 0.256 W/kg | | Acoustic Noise Levels: | 89.5 - 94.5 Typical | Note: Safety parameters of the Flexart are not changed from those cleared in the MRT-50GP 510(k) K933018. # Imaging Performance Parameters 1. Specification volume: 10 cm dsv 2. Signal to Noise Ratio (typical): - Transaxial: 73.2 - Coronal: 62.3 - Sagittal: 61.2 3. Uniformity: Not Applicable 4. Geometric Distortion: Not Applicable 5. Slice profile in the orthogonal planes: Not Applicable 6. Slice thickness: Not Applicable 7. Interslice spacing: Not Applicable # Indications for Use General disease and vascular imaging of the head and cervical regions A2 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K961391](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K961391) **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