(89 days)
No
The document does not mention AI, ML, or related terms, and the device description focuses on hardware and standard imaging techniques.
No.
The device is described as a Magnetic Resonance Imaging system intended for imaging and fluid visualization, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "Imaging of: The Whole Body..." and lists various medical applications such as "MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography," which are all diagnostic imaging procedures used to identify medical conditions.
No
The device description explicitly lists multiple hardware components, including coils, a monitor, and hard disk drives, indicating it is a hardware-based system with software components, not a software-only device.
Based on the provided text, 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 Imaging 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 testing samples taken from the body.
- Intended Use: The intended use describes imaging of various parts of the body and specific imaging techniques (MRCP, MR Angiography, etc.). These are all related to generating images of internal structures, not analyzing biological samples.
Therefore, this device falls under the category of medical imaging equipment, not in vitro diagnostics.
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 Cisternography, 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
Diffusion Imaging
The EPI Plus optional package adds the following to the above indications: Perfusion Imaging
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
This submission consists of a new Magnetic Resonance Imaging system which is based primarily on the cleared EXCELARTTM (K990620) with the following new functions added to the standard system.
• Pianissimo: Gradient acoustic reduction system
• QD Whole Body coil
• QD Head coil
• QD C/T/L Spine Array coil
• 18.1" LCD flat screen monitor
• Increase of SAR limit from
§ 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
993803
510(k) Premarket Notification
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | DEVICE NAME:
Model Number:
Trade/Proprietary Name: | Magnetic Resonance Diagnostic Device Accessory
MRT-1500 /P2
EXCELARTTM with Pianissimo | 7. SAFETY PARAMETERS: | EXCELART™ | EXCELART™
w/Pianissimo |
|----|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|-------------|---------------------------|
| 2. | ESTABLISHMENT REGISTRATION: | 2636923 | Maximum static field strength: | 1.5T | 1.5T |
| 3. | U.S. AGENT NAME AND ADDRESS: | Toshiba America MRI, Inc.
280 Utah Avenue
South San Francisco, CA 94080 | Rate of change of magnetic field: | 19.5 T/sec. | 19.35 T/sec. |
| | CONTACT PERSON: | Ken Nehmer
(650)872-2722 ext. 6083 | Maximum radio frequency power | ✓ OR Over-The-Counter Use ______ |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K993803 |
Concurrence of CDRH, Office of Device Evaluation (ODE)