(78 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware modifications and existing software from a cleared predicate device. There is no mention of AI/ML in the intended use, device description, or performance study sections.
No.
The device is described as a Magnetic Resonance Imaging system intended for imaging various parts of the body, which is a diagnostic function, not a therapeutic one.
Yes
The device is a Magnetic Resonance Imaging (MRI) system, which is used to create images of the body for the purpose of diagnosis. The "Intended Use / Indications for Use" section explicitly states "Imaging of: - The Whole Body..." which is the process of generating images from which medical conditions can be diagnosed.
No
The device description explicitly states it is a "new Magnetic Resonance Imaging system" which includes a "short bore magnet and gantry design," indicating it is a hardware system with associated software, not a software-only device.
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, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a Magnetic Resonance Imaging (MRI) system. MRI is an imaging modality that uses magnetic fields and radio waves to create images of the inside of the body. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use clearly states "Imaging of: The Whole Body..." and lists various anatomical sites and imaging techniques. This is consistent with the function of an in-vivo imaging device, not an in-vitro diagnostic device.
Therefore, based on the provided information, this device is an in-vivo imaging device, not an IVD.
N/A
Intended Use / Indications for Use
Imaging of:
- The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, . spine, blood vessels , limbs and extremities). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac tagging.]
- . Fluid Visualization
- 2D/3D Imaging
- MR Angiography/MR Vascular Imaging
- Blood Oxygenation Level Dependent (BOLD) Imaging .
Diagnostic imaging of the whole body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities), fluid visualization, 2D and 3D imaging, MR angiography/MR Vascular Imaging and MR fluoroscopy, Blood Oxygenation Level Dependent (BOLD) Imaging. [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac Tagging.}
Product codes
90 LNH
Device Description
This submission consists of a new Magnetic Resonance Imaging system which is based primarily on the cleared VISART™/Hyper system (K965068) with modifications including a short bore magnet and gantry design. The software used with the EXCELART MRI system is V4 (K983110). All other technology used for the EXCELART system is the same as that of the cleared VISART™/Hyper system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
MAY 1 4 1999
K990620
510(k) Premarket Notification
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | DEVICE NAME:
Model Number: | Magnetic Resonance Diagnostic Device Accessory
MRT-150 /V2 (EXCELART) | | |
|----|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|--|
| | Trade/Proprietary Name: | EXCELART | | |
| 2. | ESTABLISHMENT REGISTRATION: | 2636923 | | |
| 3. | U.S. AGENT NAME AND ADDRESS: | Toshiba America MRI, Inc.
280 Utah Avenue
South San Francisco, CA 94080 | | |
| | CONTACT PERSON: | Ken Nehmer
(650)872-2722 ext. 6083 | | |
| 4. | MANUFACTURING SITE: | Toshiba Corporation
1385 Shimoisigami
Otawara-shi, Tochigi-Ken
Japan 324 | | |
| 5. | DATE OF SUBMISSION: | February 24, 1999 | | |
| 6. | DEVICE DESCRIPTION: | This submission consists of a new Magnetic Resonance
Imaging system which is based primarily on the cleared
VISART™/Hyper system (K965068) with modifications
including a short bore magnet and gantry design. The
software used with the EXCELART MRI system is V4
(K983110). All other technology used for the EXCELART
system is the same as that of the cleared VISART™/Hyper
system. | | |
| 7. | SAFETY PARAMETERS:
Maximum static field strength: | VISART™/Hyper
1.5T | EXCELART
1.5T | |
| Rate of change of magnetic field: | 19.5 T/sec. | 19.35 T/sec. |
|---|---|---|
| Maximum radio frequency power |