← Product Code [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH) · K961624 # FLEXART TMJ COIL (K961624) _Toshiba America Mri, Inc. · LNH · Oct 18, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K961624 ## Device Facts - **Applicant:** Toshiba America Mri, Inc. - **Product Code:** [LNH](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH.md) - **Decision Date:** Oct 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Device Story Flexart™ Bilateral TMJ Coil; accessory for magnetic resonance imaging (MRI) systems. Device captures radiofrequency signals from TMJ region; transforms signals into anatomical images via MRI system processing. Used in clinical radiology settings; operated by MRI technicians/radiologists. Output viewed on MRI console; assists clinicians in diagnosing TMJ pathology. Benefits include high-resolution imaging of TMJ structures for improved diagnostic accuracy. ## Clinical Evidence Bench testing only. Performance parameters provided include signal-to-noise ratios (Transaxial: 167, Coronal: 154, Sagittal: 224) and safety metrics (static field strength 0.5T, RF power deposition 0.256 W/kg). Uniformity, geometric distortion, and slice profiles remain unchanged from predicate systems. ## Technological Characteristics Bilateral TMJ surface coil for MRI. Materials consistent with previously cleared Toshiba coils. Operates at 0.5 Tesla static field strength. RF power deposition 0.256 W/kg. Acoustic noise 89.5-94.5 dB. Connectivity via standard MRI coil interface. No changes to tuning/detuning schemes. ## 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 - 100mm surface coil ([K933018](/device/K933018.md)) - MRT-150A Bilateral TMJ Coil ([K943021](/device/K943021.md)) ## Reference Devices - MRT-50GP ([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} Appendix A # 510(k) Summary K961624 OCT 18 1996 Date: 23 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 - Bilateral TMJ Coil Classification: Class II-90LNH, per 21 CFR 892.1000 Device Tier: 2, according to the December 15, 1993 DRAERD Triage Pilot Program Common Name: Bilateral TMJ Coil Proprietary Name: Flexart™ Bilateral TMJ Coil Model Name: Flexart™ 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 new Flexart™ Bilateral TMJ Coil is compared to the 100mm surface coil cleared with the Flexart™ 510(k) K933018 and the MRT-150A Bilateral TMJ Coil cleared in K943021. The coils share similar Signal-to-Noise ratios, attachment schemes, tuning and detuning schemes and safety parameters. The Flexart™ Bilateral TMJ Coil does not change the previously cleared safety parameters of the Flexart™ system. Manufacturing methodology and software verification and validation procedures for the Flexart™ remain unchanged. Patient contact materials are the same as those previously cleared for other Toshiba coils. 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 head, 20 cm dsv body 2. Signal to Noise Ratio (typical): - Transaxial: 167 - Coronal: 154 - Sagittal: 224 3. Uniformity: Unchanged 4. Geometric Distortion: Unchanged 5. Slice profile in the orthogonal planes: Unchanged 6. Slice thickness: Unchanged 7. Interslice spacing: Unchanged # Indications for Use General disease of the TMJs --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K961624](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LNH/K961624) **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