(209 days)
No
The document describes software and hardware upgrades to an existing MRI system, focusing on imaging capabilities, gradient strength, and coil technology. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as an imaging system (MR Imaging) used for diagnosis, not for treating diseases or conditions.
Yes
The device is a Magnetic Resonance Imaging (MRI) system, which is used for imaging various parts of the body. Medical imaging devices like MRI are considered diagnostic devices because they produce images used by healthcare professionals to identify and assess medical conditions.
No
The device description explicitly states that the submission consists of upgrades to a "system" (MRT-150/H1 and MRT-150/F1) and includes the introduction of increased gradient field strength and optional phased array coils, which are hardware components of an MRI system. While software is upgraded, the device is not solely software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states this is a Magnetic Resonance (MR) imaging system. MR imaging is a non-invasive technique that uses magnetic fields and radio waves to create images of the inside of the body. It does not involve testing samples taken from the body.
- Intended Use: The intended use is for "Imaging of: The Whole Body..." and lists various anatomical sites and imaging techniques. This is consistent with the function of an MR imaging system, not an IVD.
Therefore, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Imaging of:
- The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, -The whole body (including reast). [Application terms include MR Fluoroscopy, MR Irography, MRCP (MR Cholangiopancreatography), MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
- Fluid Visualization -
- 2D/3D Imaging -
- MR Angiography/MR Vascular Imaging -
Product codes
LNH
Device Description
This submission consists of three upgrades to the MRT-150/H1 and MRT-150/F1 (VISART™) system. The first upgrades the software from V3.1 (which was the software cleared with the VISART™ in K961092) to V3.5. The second is the introduction of the VISART™/Hyper system, which increases the gradient field strength over that of the standard VISART™ with V3.5 software. The third is the introduction of optional phased array coils.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head, Body, Extremity, Spine, Neck, TMJ, and Heart
The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, the whole body (including reast).
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)
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
1965068
JUL | 5 |997
510(k) Summary
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | Model Name: | MRT-150/H1 and MRT-150/F1 MRT-150/H2 and MRT-150/F2 |
|---|---|---|
| Device Name: | Magnetic Resonance Device | |
| Trade/Proprietary Name: | VISART™ and VISART™/Hyper | |
| 2. | Establishment Registration: | #2020563 |
| 3. | U.S. Agent Name and Address: | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92681-2068 |
| Contact Person: | Steven M. Kay (714) 730-5000 | |
| 4. | Manufacturing Site: | Toshiba Corporation 1385 Shimoishigami Otawara-shi, Tochigi-Ken Japan 324 |
ર. DATE OF SUBMISSION: 16 December 1996
DEVICE DESCRIPTION 6.
This submission consists of three upgrades to the MRT-150/H1 and MRT-150/F1 (VISART™) system. The first upgrades the software from V3.1 (which was the software cleared with the VISART™ in K961092) to V3.5. The second is the introduction of the VISART™/Hyper system, which increases the gradient field strength over that of the standard VISART™ with V3.5 software. The third is the introduction of optional phased array coils.
1
7. SAFETY PARAMETERS
| | VISARTTM
V3.1 | VISARTTM
V3.5 | VISARTTM/Hyper
V3.5 |
|------------------------------------------------|-----------------------|-----------------------|------------------------|
| Maximum static field strength: | 1.5T | Same | Same |
| Rate of change of magnetic field (τ = 1000ms): | 13.3T/sec, | 13.3T/sec. | 19.5T/sec. |
| Max. Radio frequency power deposition: | (Division Sign-Off) |
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K965068 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |