(175 days)
Not Found
No
The summary describes a passive accessory (a coil) for an MRI device and contains no mention of AI, ML, or image processing capabilities.
No
The device is described as a "Magnetic Resonance Device Accessory - Bilateral TMJ Coil" and is used for "General disease of the TMJs." This indicates it's an imaging accessory for diagnosis, not a device that provides therapy. Its predicate devices are also imaging coils.
Yes
The device is described as a "Magnetic Resonance Device Accessory" for "General disease of the TMJs," with "Magnetic Resonance" as the Input Imaging Modality. Magnetic Resonance imaging is a diagnostic imaging technique, and an accessory for such a device used to identify disease indicates a diagnostic purpose.
No
The device is described as a "Magnetic Resonance Device Accessory - Bilateral TMJ Coil," which is a hardware component used in MRI.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "General disease of the TMJs," which refers to a condition within the body, not the analysis of samples taken from the body.
- Device Description: The device is described as a "Magnetic Resonance Device Accessory - Bilateral TMJ Coil." This is a component used with an imaging system (MRI) to visualize internal structures.
- Input Imaging Modality: The input is "Magnetic Resonance," which is an imaging technique, not a method for analyzing biological samples.
- Anatomical Site: The anatomical site is "TMJs," which are joints within the body.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device is used to image a part of the body directly.
N/A
Intended Use / Indications for Use
General disease of the TMJs
Product codes
LNH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
TMJs (Temporomandibular Joints)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.
0
Appendix A
510(k) Summary
| Date: | 23 April 1996 OCT 18 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 CoilTM |
| Proprietary Name: | FlexartTM Bilateral TMJ Coil |
| Model Name: | FlexartTM |
| 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.
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 Depostion: | 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