(90 days)
Not Found
No
The device description focuses solely on the hardware components and their function in receiving RF signals for MRI. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an "RF coil" for "vascular imaging of the head and cervical regions" and functions as an extension of a "Cervical Collar" for a Magnetic Resonance imaging system. Its purpose is to capture RF signals for imaging, not to provide therapy.
No
The device description states it is a "Head and Neck Coil" which is a component of an MRI system used for imaging. Imaging devices are used to collect data, not to diagnose conditions. While the images produced by the MRI system (with this coil) are used for diagnosis, the coil itself is a data acquisition component, not a diagnostic device.
No
The device description explicitly details hardware components like coils, loops, varactors, amplifiers, and diodes, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "Flexart™ Head and Neck Coil" used for "General disease and vascular imaging of the head and cervical regions." This is a component of a Magnetic Resonance (MR) imaging system.
- Imaging Modality: The input imaging modality is Magnetic Resonance, which is an in-vivo imaging technique, not an in-vitro diagnostic test.
- Anatomical Site: The device is used on the "head and cervical regions" of the patient, not on a sample taken from the patient.
The device is a medical device used for diagnostic imaging, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
General disease and vascular imaging of the head and cervical regions
Product codes
LNH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head and cervical regions
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)
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.
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
Imaging Performance Parameters:
Specification volume: 10 cm dsv
Signal to Noise Ratio (typical): Transaxial: 73.2, Coronal: 62.3, Sagittal: 61.2
Uniformity: Not Applicable
Geometric Distortion: Not Applicable
Slice profile in the orthogonal planes: Not Applicable
Slice thickness: Not Applicable
Interslice spacing: Not Applicable
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
)) !! 9 1996
510(k) Summary
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 - OD 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.
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 |
|---|---|
| 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