(78 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware and software upgrades without mentioning AI/ML capabilities.
No
The device is described as an imaging system (MRI) used for diagnosis, not for treating any condition. Its intended uses are "Imaging of the whole body," "fluid visualization," "2D/3D Imaging," "MR Angiography," and "MR Fluoroscopy," all of which are diagnostic functions.
Yes
The device, described as an "Imaging of the whole body... fluid visualization, 2D/3D Imaging, MR Angiography, MR Fluoroscopy," clearly indicates its purpose is to create images of the body for medical assessment, which is a key function of a diagnostic device.
No
The device description explicitly states it is an upgrade to an existing MRT-35A system, which includes a superconducting magnet, gradient system, and coil set. The upgrade replaces the computer system but is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Imaging of the whole body...". This describes a medical imaging device used to visualize internal structures of the body.
- Device Description: The description clearly states it's an "MRT-35A system which uses a 0.35T superconducting magnet," which is a type of Magnetic Resonance Imaging (MRI) system.
- Nature of IVDs: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
The information provided consistently points to a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The MRT-35A v9.0 is a modification of the MRT-35A system which uses a 0.35T superconducting magnet. The MRT-35A v9.0 is an incremental upgrade to an MRT-35A system which is configured with version 8 hardware and software. The 9.0 upgrade replaces the version 8 computer system. The computer architecture, operational characteristics and user software follow the same design considerations cleared by Flexart™ and Visart™ systems. This 9.0 upgrade makes no change to the MRT-35A version 8 series magnet, gradient system or coil set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head, Body, Spine, Neck, TMJ, and Heart
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
Sample phantom images and clinical images were presented for all new sequences, demonstrating conformance with consensus standards requirements for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion and Slice Thickness/Interslice Spacing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
FEB - 4 1997
510(k) Summary
Magnetic Resonance Device Accessory 1. DEVICE NAME: MRT-35A v9.0 Model Number Trade/Propriety Name: MRT-35A v9.0 ESTABLISHMENT REGISTRATION: 2936923 2. Toshiba America MRI, Inc. 3. U.S. Agent Name and Address: 280 Utah Avenue South San Francisco, California 94080 Contact Person Steven M. Kay (714) 730-5000 Manufacturing Site Toshiba America MRI, Inc. 4. 280 Utah Avenue South San Francisco, California 94080 DATE OF SUBMISSION: November 15, 1996
DEVICE DESCRIPTION 6.
The MRT-35A v9.0 is a modification of the MRT-35A system which uses a 0.35T superconducting magnet. The MRT-35A v9.0 is an incremental upgrade to an MRT-35A system which is configured with version 8 hardware and software. The 9.0 upgrade replaces the version 8 computer system. The computer architecture, operational characteristics and user software follow the same design considerations cleared by Flexart™ and Visart™ systems. This 9.0 upgrade makes no change to the MRT-35A version 8 series magnet, gradient system or coil set.
7. SAFETY PARAMETERS
| MRT-35A | MRT-35A | Flexart™ | |
|---|---|---|---|
| 9.0 Upgrade | 8.0 Upgrade | ||
| Maximum static field strength: | 0.35 T | same | 0.5 T |
| Rate of change of magnetic field: | 6.83 T/sec | same | 11 T/sec |
| Max. radio frequency power deposition: | 0.3 W/kg | 0.34 W/kg |