(203 days)
No
The summary describes software and hardware upgrades to an existing MRI system, focusing on new scanning sequences and fat suppression techniques. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is used for imaging and diagnostic purposes (MR imaging, MR Angiography, MR Fluoroscopy) and does not provide any form of therapy.
No
The device is an imaging system (MRI) used for visualization, not for diagnosing conditions based on the images. While images are used in diagnosis, the device itself produces images and isn't characterized as a diagnostic device in this context.
No
The device description explicitly states it is "software consists of two model upgrades to the FLEXART™ system" and mentions hardware components like "gradient field strength." This indicates it is software that modifies or enhances a hardware system, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes imaging of the human body and its structures using Magnetic Resonance technology. This is a diagnostic imaging device, not a device used to examine specimens (like blood, urine, or tissue) outside of the body.
- Device Description: The description details software upgrades for an MR system, focusing on scanning features and fat suppression techniques. This aligns with the function of an imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
In summary, the device is a Magnetic Resonance Imaging (MRI) system, which is a type of medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.
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
Version 3.1 software consists of two model upgrades to the FLEXARTTM system. The MRT-50GP/E2 (FlexartTM) includes such new applicational features as FastASE, QuadScan and MR Fluoroscopy for scanning and MSOFT and PASTA for fat supression. The MRT-50GP/H1 (FlexartTM/Hyper) increases the gradient field strength over that of the FlexartTM .
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
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)
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
DEC 2 3 1996
510(k) Summary
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | Model Name: | MRT-50GP/E2 and MRT-50GP/H1 | |
|---|---|---|---|
| Device Name: | Magnetic Resonance Device | ||
| Trade/Proprietary Name: | FLEXARTTM V3.1 |
- Establishment Registration: 2. #2936923
- TOSHIBA AMERICA MRI, INC. 3. U.S. Agent Name and Address: 280 Utah Ave. South San Francisco, CA 94080
Steven M. Kay Contact Person: (714) 730-5000
- Toshiba Corporation Manufacturing Site: 4. 1385 Shimoishigami Otawara-shi, Tochigi-Ken Japan 324
May 30 1996 5. DATE OF SUBMISSION:
ર. DEVICE DESCRIPTION
Version 3.1 software consists of two model upgrades to the FLEXART™ system. The MRT-50GP/E2 (Flexart™) includes such new applicational features as FastASE, QuadScan and MR Fluoroscopy for scanning and MSOFT and PASTA for fat supression. The MRT-50GP/H1 (Flexart™/Hyper) increases the gradient field strength over that of the Flexart™ .
SAFETY PARAMETERS 7.
| MRT-50GP | MRT-50GP/E2 | MRT-50G/H1 | |
|---|---|---|---|
| Maximum static field strength: | 0.5 T | Same | Same |
| Rate of change of magnetic field (τ = 1000ms): | 11 T/sec, | Same | 13.3 T/sec. |
| Max. Radio frequency power deposition: | MRT-150A | MRT-150/H1 | MRT-150/F1 |
| ----------------------- | ------- | ----------------- | ------------------- |
| Specification volume: | Head: | 10.4 cm dsv | 14 cm dsv |
| Body: | 10.4 cm dsv | 28 cm dsv |
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.
INTENDED USE 9.
| 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. |
10. EQUIVALENCY INFORMATION
Toshiba America Medical Systems, Inc. (TAMS) believes the FLEXART™ and FLEXARTM/HYPER systems with V3.1 are substantially equivalent to the MRT-50GP FLEXART™ because they consist of hardware and software upgrades that improve the performance of the basic FLEXART™, without introducing new questions of safety or efficacy. The FLEXART™ was cleared by K933018. The increased gradient field strength is less than the IEC standard and that of other manufacturers systems currently on the market. New surface coils for this system received prior market clearance from the Agency. Software upgrades provide for improved image quality, but do not change the intended uses of the device. MR Fluoroscopy is similar to the same function that was cleared for the MRT-35A. Good Manufacturing Practices requirements are unchanged from those already in effect for the FLEXART™.