(14 days)
Not Found
No
The document describes a hardware upgrade (high performance gradient system) and modified sequences for faster acquisition, but does not mention any AI or ML components or functionalities.
No.
The device is described as an imaging system (Magnetic Resonance Imaging - MRI) used for diagnostic purposes, not for treating diseases or conditions.
Yes
The device is an 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 implies the generation of images for diagnostic interpretation.
No
The device description explicitly states it is a "system" that incorporates a "high performance gradient system" and offers "modified sequences for the faster acquisition." This indicates the device includes hardware components (the gradient system) and is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is focused on imaging the human body using Magnetic Resonance Imaging (MRI). This is a diagnostic imaging technique that visualizes internal structures and functions.
- Device Description: The device is described as an MRI system with a high-performance gradient system for faster image acquisition.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information about a physiological state, health, or disease. IVDs are typically used in laboratories or point-of-care settings to analyze these types of samples.
Therefore, this device falls under the category of 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, neck, . TMJ, heart, blood vessels). {Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.]
- Fluid Visualization .
- 2D / 3D Imaging ●
- MR Angiography / MR Vascular Imaging .
- . Water / Fat Imaging
- Perfusion / Diffusion Imaging .
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The OPART™ /Ultra system is added into existing OAPRT™ series by incorporating the high performance gradient system. The OPART™ /Ultra system and the OPART™ system with Ultra gradient upgrade kit offers the modified sequences for the faster acquisition than existing OPART™ systems. The following model number with suffix corresponds to the Trade/Proprietary Name respectively.
MRT-600EX /PR - OPART TM
MRT-600EX /UH - OPART TM /Ultra (Manual bed model)
MRT-600EX /U1 - OPART TM /Ultra (Motorized bed model)
MZKT-GP0302 /U1 - OPART TM Ultra gradient system upgrade kit
The following five versions have the same base software features with certain additional features available in each subsequent version (see Comparison Table, Appendix 7, for detailed description). A brief description follows:
V4.0: V4.00 onto v3.0 (K993574)
V4.1: V4.00 onto v3.1 (K993574)
V4.2: V4.00 onto v3.2 (K993574)
V4.3: V4.00 onto v3.3 (K993574)
V4.4: Based on v3.3 (K993574) with addition of fast acquisitions. This software is only available for OPART™ /Ultra system.
A brief summary of the changes are described below:
SUMMARY OF MAJOR HARDWARE CHANGES 6.1.
A. For the OPART™ /Ultra system, the existing gradient amplifier in the control cabinet is eliminated and the high performance gradient power supply is added as a stand alone cabinet.
B. For the OPART™ /Ultra system, the cooling pipes are integrated into the gradient coils.
C: All the OPART™ standard configuration has only Open TX coil and QD Head coil, and other RF coils are moved to the options.
D. QD/Array Neck coil (K000549) is added in the optional items.
E. OD/Array Shoulder coil (K013854) is added in the optional items.
F. QD C/T/L Array Spine coil (K(X00002) is added in the optional items.
6.2. SUMMARY OF MAJOR SOFTWARE CHANGES
A. Improved user interface. (for V4.0, V4.1, V4.2, V4.3, V4.4)
B. High performance gradient power supply control (only for V4.4)
C. Single Shot EPI (SS-EPI) (only for V4.4)
D. Advanced Steady State Free Precession (SSFP) (only for V4.4)
E. Super FASE, shorter . TE version of FASE. (only for V4.4)
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.
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
Ko 23207
OCT 0 9 2002
Appendix 1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. DEVICE NAME: | |
|---|---|
| ----------------- | -- |
Model Name:
Trade/Proprietary Name:
Magnetic Resonance Diagnostic Device Accessory
MRT-600EX
OPARTTM
including OPART™ /Ultra and Ultra gradient system upgrade kit
ESTABLISHMENT REGISTRATION: 2020563 2.
-
- U.S. Agent Name and Address:
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DRIVE TUSTIN, CA 92780
- U.S. Agent Name and Address:
Contact Person:
- Manufacturing Site: Michaela Mahl (714) 730 - 5000
TOSHIBA CORPORATION MEDICAL SYSTEMS COMPANY 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan
August 01, 2002 ട. DATE OF SUBMISSION:
DEVICE DESCRIPTION 6.
The OPART™ /Ultra system is added into existing OAPRT™ series by incorporating the high performance gradient system. The OPART™ /Ultra system and the OPART™ system with Ultra gradient upgrade kit offers the modified sequences for the faster acquisition than existing OPART™ systems. The following model number with suffix corresponds to the Trade/Proprietary Name respectively.
| Model Number with suffix | Trade/Proprietary Name |
|---|---|
| MRT-600EX /PR | OPART TM |
| MRT-600EX /UH | OPART TM /Ultra (Manual bed model) |
| MRT-600EX /U1 | OPART TM /Ultra (Motorized bed model) |
| MZKT-GP0302 /U1 | OPART TM Ultra gradient system upgrade kit |
The following five versions have the same base software features with certain additional features available in each subsequent version (see Comparison Table, Appendix 7, for detailed description). A brief description follows:
V4.0: V4.00 onto v3.0 (K993574)
V4.1: V4.00 onto v3.1 (K993574)
1
V4.00 onto v3.2 (K993574) V4.2:
- V4.3: V4.00 onto v3.3 (K993574)
- Based on v3.3 (K993574) with addition of fast acquisitions. This software is only V4.4: available for OPART™ /Ultra system.
A brief summary of the changes are described below:
SUMMARY OF MAJOR HARDWARE CHANGES 6.1.
A. For the OPART™ /Ultra system, the existing gradient amplifier in the control cabinet is eliminated and the high performance gradient power supply is added as a stand alone cabinet.
B. For the OPART™ /Ultra system, the cooling pipes are integrated into the gradient coils.
C: All the OPART™ standard configuration has only Open TX coil and QD Head coil, and other RF coils are moved to the options.
D. QD/Array Neck coil (K000549) is added in the optional items.
E. OD/Array Shoulder coil (K013854) is added in the optional items.
F. QD C/T/L Array Spine coil (K(X00002) is added in the optional items.
6.2. SUMMARY OF MAJOR SOFTWARE CHANGES
A. Improved user interface. (for V4.0, V4.1, V4.2, V4.3, V4.4)
B. High performance gradient power supply control (only for V4.4)
C. Single Shot EPI (SS-EPI) (only for V4.4)
D. Advanced Steady State Free Precession (SSFP) (only for V4.4)
E. Super FASE, shorter . TE version of FASE. (only for V4.4)
SAFETY PARAMETERS 7.
| | OPART™ (No changes from the
previous submission, K993574) | OPART™ /Ultra |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------|
| a. Static field strength: | 0.35 T | Same |
| b. Peak and A-weighted acoustic
noise: | 108 dB (Peak)
98.4 dB(A-weighted) | 115.4 dB (Peak)
102.5 dB(A-weighted) |
| c. Operational modes:
i. Safety parameter display:
ii. Operating mode access
requirements: | Normal operating mode
SAR
Not applicable because used
only in normal operating mode | Same
Same
Same |
| d. Maximum SAR |