(88 days)
Flexart™, Access™
NOT APPLICABLE
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware modifications and existing software architecture.
No
The device description and intended use clearly indicate that it is an imaging system (MRI) used for diagnostic purposes, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states "Imaging of the whole body... fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy." These are all functions characteristic of diagnostic imaging devices.
No
The device description explicitly states it is a modification of a physical MRI system (Flexart™ 0.5T) and includes details about the magnet, patient couch, and field strength, indicating it is a hardware-based medical device. While it mentions user software, it is part of a larger hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that this device is a Magnetic Resonance (MR) system. MR systems are imaging devices that use magnetic fields and radio waves to create images of the inside of the body. They do not analyze specimens taken from the body.
- Intended Use: The intended use is for "Imaging of the whole body... fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy." This is consistent with the function of an imaging device, not an IVD.
Therefore, based on the provided information, this device is a medical imaging system, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
| Anatomical Region: | Head, Body, Extremity, Spine, Neck, TMJ, and Heart |
|---|---|
| Nuclei excited: | Hydrogen |
| Diagnostic Use: | Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR. Fluoroscopy |
Product codes
Not Found
Device Description
The OPART™ is a modification of the Flexart™ 0.5T system that employes a 0.35T open architecture vertical field superconducting magnet. The computer architecture. operational characteristics and user software follow the same design considerations cleared with the Flexart™ and Visart™ systems. The vertical magnetic field concept is similar to that developed for the Access™ permanent magnet system but uses the same 0.35T field strength as that employed by the MRT-35A. The patient couch allows both manually controlled left/right and in/out horizontal movements similar to the Access Compass Bed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head, Body, Extremity, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Flexart™, Access™
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
510(k) Summary
- OCT 2 5 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
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- DEVICE NAME: Magnetic Resonance Device Model Number: ' MRT-600 Trade/Proprietary Name: OPARTTM 2. ESTABLISHMENT REGISTRATION: 2936923 3. U.S. Agent Name and Address: TOSHIBA AMERICA MRI, INC. 280 Utah Ave. South San Francisco, CA 94080 Contact Person: Steven M. Kay (714) 730-5000
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- Manufacturing Site: Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080
-
- DATE OF SUBMISSION: July 26, 1996
6. DEVICE DESCRIPTION
The OPART™ is a modification of the Flexart™ 0.5T system that employes a 0.35T open architecture vertical field superconducting magnet. The computer architecture. operational characteristics and user software follow the same design considerations cleared with the Flexart™ and Visart™ systems. The vertical magnetic field concept is similar to that developed for the Access™ permanent magnet system but uses the same 0.35T field strength as that employed by the MRT-35A. The patient couch allows both manually controlled left/right and in/out horizontal movements similar to the Access Compass Bed.
7. SAFETY PARAMETERS
| OPART | Flexart | Visart | |
|---|---|---|---|
| Maximum static field strength: | 0.35T | 0.5T | 1.5T |
| Rate of change of magnetic field (T = 1000ms): | 18.5 T/sec | 11 T/sec, | 13.3T/sec. |
| Max. Radio frequency power deposition: |