(157 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on software upgrades and new coils, not AI/ML capabilities.
No
The device is described as an imaging system (Magnetic Resonance) used for diagnostic purposes, not for treating conditions.
Yes
The device is a magnetic resonance imaging (MRI) system, which is used to create images of the body for diagnostic purposes, as indicated by its "Intended Use" to image various body parts and fluid visualization, as well as MR angiography/vascular imaging.
No
The device description explicitly states that the submission consists of two upgrades: V3.5 software and the introduction of phased array coils. The inclusion of physical coils indicates it is not a 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 various parts of the human body using Magnetic Resonance. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) outside of the body.
- Device Description: The description details software and hardware upgrades for an MRI system, which is consistent with an imaging device.
- No mention of in vitro testing: There is no mention of analyzing biological samples or performing tests on specimens outside of the body.
IVD devices are specifically designed for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to create images of the internal structures of the body.
N/A
Intended Use / Indications for Use
Imaging of:
- The Whole Body (including head, abdomen, pelvis, limbs and extremities, joints, spine, neck, -TMJ, heart, blood vessels, and breast). [Application terms include MRCP (MR Frida, nours, ever a reasony, MR Myeiography, MR Myeiography, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
- Fluid Visualization -
- 2D/3D Imaging .
- MR Angiography/MR Vascular Imaging -
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
This submission consists of two upgrades to the MRT-50GP/E2 (FLEXART™) and MRT-50GP/H2 (FLEXART™/Hyper) system. The first is the V3.5 software, which is an upgrade over the V3.1 software. The second is the introduction of phased array coils into the coil lineup.
Maximum static field strength: 1.5T
Rate of change of magnetic field (τ = 1000ms): 11 (13.3)T/sec.
Max. Radio frequency power deposition:
§ 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
Image /page/0/Picture/1 description: The image shows the word "TOSHIBA" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is horizontally oriented and appears to be a logo or brand name.
MERICA MEDICAL SYSTEMS, INC. RIVE, P.O. BOX 2068
510(k) Summary JUL 21 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | Model Name:
Device Name:
Trade/Proprietary Name: | MRT-50GP/E2 and MRT-50GP/H2
Magnetic Resonance Device
FLEXART™/FLEXART™/Hyper V3.5 |
|----|--------------------------------------------------------|------------------------------------------------------------------------------------------|
| 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 |
| 4. | Manufacturing Site: | Toshiba Corporation
1385 Shimoishigami
Otawara-shi, Tochigi-Ken
Japan 324 |
February 12, 1997 న. DATE OF SUBMISSION:
DEVICE DESCRIPTION 6.
This submission consists of two upgrades to the MRT-50GP/E2 (FLEXART™) and MRT-50GP/H2 (FLEXART™/Hyper) system. The first is the V3.5 software, which is an upgrade over the V3.1 software. The second is the introduction of phased array coils into the coil lineup. More detailed descriptions appear below.
7. SAFETY PARAMETERS [ ( ):FLEXART™/Hyper]
| V3.1 | V3.5 | |
|---|---|---|
| Maximum static field strength: | 1.5T | Same |
| Rate of change of magnetic field (τ = 1000ms): | 11 (13.3)T/sec, | 11 (13.3)T/sec. |
| Max. Radio frequency power deposition: | ✓ | |
| OR | Over-The-Counter Use |
CONFIDENTIAL - 10