(87 days)
K903768A, K933018
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware and software upgrades for image quality without mentioning AI/ML.
No
The device is described as an imaging system used for visualization, indicating it is a diagnostic tool rather than a therapeutic one.
Yes
The device is described as "Imaging of the whole body" and states "Sample phantom images and clinical images were presented," indicating its purpose is to create images that healthcare professionals can use for diagnosis.
No
The device description explicitly states it consists of hardware components (gradient field strength, computer architecture, magnet) in addition to software upgrades.
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 body 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 a Magnetic Resonance system, which is a piece of medical imaging equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
In vitro diagnostics are tests performed on samples taken from the human body to detect diseases, conditions, or infections. This device is used to create images of the body itself.
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 (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The VISART™ consists of two model upgrades to the MRT-150A system which provide increased gradient field strength, more ergonomic computer architecture, improved scan parameter specifications and a lighter magnet than the MRT-150A.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K903768A, K933018
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
1
JUN 1 4 1996
510(k) Summary
SUMMARY OF SAFETY AND EFFECTIVENESS
- MRT-150A/H1 and MRT-150A/F1 Model Name: 1. Magnetic Resonance Device Device Name: VISARTTM Trade/Proprietary Name:
-
- Establishment Registration: #2020563
1 11 11 16 11
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. U.S. Agent Name and Address: 3. 2441 Michelle Drive P.O. Box 2068 Tustin, CA 92681-2068
Contact Person: Steven M. Kay (714) 730-5000
- Toshiba Corporation Manufacturing Site: 4. 1385 Shimoishigami Otawara-shi, Tochigi-Ken Japan 324
5. DATE OF SUBMISSION: March ? 1996
DEVICE DESCRIPTION 6.
The VISART™ consists of two model upgrades to the MRT-150A system which provide increased gradient field strength, more ergonomic computer architecture, improved scan parameter specifications and a lighter magnet than the MRT-150A.
7. SAFETY PARAMETERS
| MRT-150A | MRT-150/H1 | MRT-150/F1 | |
|---|---|---|---|
| Maximum static field strength: | 1.5T | Same | Same |
| Rate of change of magnetic field ( $\tau$ = 1000ms): | 7.5T/sec, | 13.3T/sec. | 13.3T/sec. |
| Max. Radio frequency power deposition: |