(15 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware improvements and performance metrics, not AI/ML capabilities.
No
The device is an MRI system primarily used for diagnostic imaging, not for treating diseases or conditions.
Yes
The 'Intended Use / Indications for Use' section lists numerous applications like MRCP, MR Urography, MR Myelography, and various types of imaging (2D/3D, Angiography, BOLD, Perfusion/Diffusion, Proton Spectroscopy), all of which are used to visualize internal body structures and functions to aid in medical diagnosis.
No
The device description explicitly mentions hardware components like gradient strength, slew rate, and CPU clock speed, indicating it is a hardware system with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an imaging system for visualizing various parts of the human body using Magnetic Resonance Imaging (MRI). This is a diagnostic imaging modality, not an in vitro diagnostic test.
- Device Description: The description details the technical specifications and improvements of an MRI system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are the defining characteristics of an IVD.
Therefore, the EXCELART Vantage™ ZGV system is 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, t t neck, TMJ, heart, blood vessels). [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 ●
- Perfusion / Diffusion Imaging .
- Proton Spectroscopy .
Product codes
LNH
Device Description
The EXCELART Vantage™ ZGV system is comparable to the current EXCELART Vantage™ XGV/AGV system; with the following exceptions.
- The maximum gradient strength and the maximum slew rate have been increased. .
- The clock of CPU of computer system was increased from 2.8GHz to 3.2GHz. ,
- SAR 1st level operating mode as specified in IEC 60601-2-33 (2002). .
- Thel performance (Min.TR/Min.TE / Min.Slice thickness ) of a sequence has been , improved.
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, t t neck, TMJ, heart, blood vessels)
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)
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
JAN 1 8 2006
06 0003
Appendix 1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. DEVICE NAME: | Magnetic Resonance Diagnostic Device Accessory |
|---|---|
| Model Name: | MRT-1503/P5 |
| Trade/Proprietary Name: | EXCELART Vantage™ ZGV |
| 2. ESTABLISHMENT REGISTRATION: | 2020563 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 3. U.S. Agent Name and Address: 2441 MICHELLE DRIVE TUSTIN, CA 92780
Paul Biggins Contact Person: (714) 730 - 5000
- TOSHIBA CORPORATION Manufacturing Site: 4. MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
- December 22, 2005 DATE OF SUBMISSION: 5.
DEVICE DESCRIPTION 6.
The EXCELART Vantage™ ZGV system is comparable to the current EXCELART Vantage™ XGV/AGV system; with the following exceptions.
- The maximum gradient strength and the maximum slew rate have been increased. .
- The clock of CPU of computer system was increased from 2.8GHz to 3.2GHz. ,
- SAR 1st level operating mode as specified in IEC 60601-2-33 (2002). .
- Thel performance (Min.TR/Min.TE / Min.Slice thickness ) of a sequence has been , improved.
| Model Number with suffix | Trade/Proprietary Name |
|---|---|
| MRT-1503/P5 | EXCELART Vantage™ ZGV |
6.1. SUMMARY OF MAJOR HARDWARE CHANGES
- A. The gradient coil was changed for higher gradient strength and slew rate .
- B. The gradient power supply was changed for higher gradient strength and slew rate.
- C: The clock of CPU was changed from 2.8GHz to 3.2GHz.
- D. Flex coils (70, 100, 150, 200mm, Rectangular) are added to the available coil list.
- E. QD Knee/Foot coil ( K051763) is added.
1
6.2. SUMMARY OF MAJOR SOFTWARE CHANGES
- A. New CPU correspondence.
- B. New RF coil control.
- C. SAR limitation control.
7. SAFETY PARAMETERS
| | Current EXCELART
Vantage™ XGV/AGV (No
changes from the previous
submission, K032490 ) | New EXCELART
Vantage™ ZGV |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| a. Static field strength: | 1.5 T | Same |
| b. Peak and A-weighted
acoustic noise: | 110 dB (A-weighted) | Same |
| c. Operational modes: | 1st operating mode for dB/dt | 1st operating mode
for dB/dt and SAR |
| i. Safety parameter display: | SAR, dB/dt | Same |
| ii. Operating mode access
requirements: | Not applicable because used
only in normal operating
mode | Allows access to 1st
level operating mode |
| d. Maximum SAR | Normal operating mode
specified in IEC 60601-2-33
(2002) | 1st operating mode
specified in IEC
60601-2-33 (2002) |
| e. Maximum dB/dt |