(9 days)
No
The document describes hardware and performance improvements to an existing MRI system, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
No
The device is described as an imaging system, specifically a Magnetic Resonance (MR) system, used for diagnostic purposes (imaging various parts of the body, fluid visualization, angiography, perfusion/diffusion imaging, etc.). There is no mention of it being used for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly lists various imaging applications (e.g., MRCP, MR Urography, Perfusion / Diffusion Imaging, Proton Spectroscopy) and mentions imaging of different body parts and fluid visualization, which are all methods used to obtain information for diagnosis. The device description also highlights improvements in imaging performance.
No
The device description clearly outlines significant hardware components and design changes, including a new gantry design, patient couch, and CPU. This indicates it is a hardware system, not software-only.
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 technology. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body.
- Device Description: The description details the physical components and technical features of an MRI system, which is consistent with an in-vivo imaging device.
- Input Imaging Modality: The input modality is Magnetic Resonance, which is an in-vivo imaging technique.
- Anatomical Site: The anatomical site is the whole body, indicating direct interaction with the patient.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. This device is used to create images of the inside of the body directly.
N/A
Intended Use / Indications for Use
Imaging of:
- The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholanqiopancreatography), 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
- Perfusion / Diffusion Imaging .
- Proton Spectroscopy .
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The EXCELART Vantage™ XGV/AGV system has the following features compared to the current EXCELART™ with Pianissimo XG/AG SPIN Edition system.
- New gantry design as Ultra-short bore. .
- . New patient couch design as wide couch top.
- It is possible to combine detachable couch top and gurney of exclusive use. .
- . The CPU of computer system was changed from RISC type to Xeon.
- . dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33(2002) by some sequences.
- . SAR enabled use by normal operating mode specified in IEC 60601-2-33(2002).
- The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a . sequence has been improved.
- The gating waveform can be displayed by the side of the gantry. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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): 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.
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.
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
AUG 2 1 2003
Page 1 of 2
Appendix 1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. DEVICE NAME: | Magnetic Resonance Diagnostic Device Accessory |
|---|---|
| Model Name: | MRT-1503/P3, P2 |
| Trade/Proprietary Name: | EXCELART Vantage ™ XGV/AGV |
-
- ESTABLISHMENT REGISTRATION: 2020563
TOSHIBA AMERICA MEDICAL SYSTEMS,INC. U.S. Agent Name and Address: 2441 MICHELLE DRIVE
- ESTABLISHMENT REGISTRATION: 2020563
TUSTIN, CA 92780
Michaela Mahl (714) 730 - 5000
Contact Person:
Manufacturing Site: TOSHIBA CORPORATION 4. MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
-
- DATE OF SUBMISSION: July 11, 2003
6. DEVICE DESCRIPTION
The EXCELART Vantage™ XGV/AGV system has the following features compared to the current EXCELART™ with Pianissimo XG/AG SPIN Edition system.
- New gantry design as Ultra-short bore. .
- . New patient couch design as wide couch top.
- It is possible to combine detachable couch top and gurney of exclusive use. .
- . The CPU of computer system was changed from RISC type to Xeon.
- . dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33(2002) by some sequences.
- . SAR enabled use by normal operating mode specified in IEC 60601-2-33(2002).
- The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a . sequence has been improved.
- The gating waveform can be displayed by the side of the gantry. .
| Model Number with suffix | Trade/Proprietary Name |
|---|---|
| MRT-1503/P3 | EXCELART Vantage™ XGV |
| MRT-1503/P2 | EXCELART Vantage™ AGV |
1
K032490
Page 2 of 2
Appendix 1
6.1. SUMMARY OF MAJOR HARDWARE CHANGES
A. The magnet system was changed to short bore.
B. The gradient coil was changed to short bore.
C: The patient couch was changed to wide and detachable couch top.
D. It is possible to combine detachable couch top and gurney of exclusive use.
E. The whole body coil was modified for corresponds to SAR 2.0w/kg
F. 4ch flex body array coil is added in the optional items.
G. QD head SPEEDER (K022582) is added in the optional items.
H. The gating waveform can be displayed by the side of the gantry
6.2. SUMMARY OF MAJOR SOFTWARE CHANGES
- A. New CPU correspondence.
- B. New RF coils control.
- C. dB/dt limitation control.
- D. SAR limitation control.
7. SAFETY PARAMETERS
| | Current EXCELART™ with
Pianissimo XG/AG SPIN
Edition (No changes from the
previous submission,
K023511 ) | New EXCELART™
Vantage™
XGV/AGV |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| a. Static field strength: | 1.5 T | Same |
| b. Peak and A-weighted
acoustic noise: | 95.4 dB (A-weighted) | 110 dB (A-weighted) |
| c. Operational modes: | 1st operating mode for dB/dt
SAR, dB/dt | Same |
| i. Safety parameter display: | Same | Same |
| ii. Operating mode access
requirements: | Not applicable because used
only in normal operating
mode | Same |
| d. Maximum SAR |