(15 days)
No
The document describes hardware and software improvements focused on image acquisition speed, processing, and user interface, but does not mention AI or ML.
No.
The device is described as an imaging system for diagnostic purposes, not for treatment.
Yes
The device performs imaging of various anatomical sites (the whole body including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels), and specific applications like MRCP, MR Angiography, Perfusion/Diffusion Imaging, and Proton Spectroscopy. These imaging capabilities are used to aid in the diagnosis of medical conditions.
No
The device description clearly outlines hardware components and modifications, including extensions to the receiving system, use of a QD Torso SPEEDER, a dedicated reconstruction computer, changes to field strength, and a redesigned gating unit. This indicates it is a hardware system with associated software, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly indicate that this device is an imaging system (Magnetic Resonance Imaging - MRI) used to image the inside of the human body directly. It does not process or analyze samples like blood, urine, or tissue outside the body.
- The intended use describes imaging procedures. The listed applications like MRCP, MR Angiography, Perfusion/Diffusion Imaging, and Proton Spectroscopy are all imaging techniques performed on a living patient.
- The device description focuses on hardware and software for image acquisition and processing. Features like the receiving system, parallel imaging, reconstruction computer, and field strength are all related to the technical aspects of generating and processing MRI images of the body.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
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 Cisternography, MR Myelography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging and Cardiac tagging.] { K002531 }
- Fluid Visualization { K002531 }
- 2D / 3D Imaging { K002531}
- MR Angiography / MR Vascular Imaging {K002531}
- Blood Oxygenation Level Dependent (BOLD) imaging { K002531}
- Perfusion / Diffusion Imaging {K993803, K002531}
- Proton Spectroscopy { K010129}
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The EXCELART™ with Pianissimo XG/AG SPIN Edition system has the following features compared to the current EXCELART™ with Pianissimo XG/AG system.
- Extension of a receiving system is enabled a maximum of 8 ch. .
- Use of QD Torso SPEEDER corresponding to Parallel imaging which can shorten scan time is . enabled.
- The computer only for reconstruction was carried for high-speed image processing. .
- . dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33 by the TrueSSFP sequence.
- Max. field strength is changed 25mT/m to 30mT/m. .
- . The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a sequence has been improved.
- The user interface of software was changed for the improvement of operativity. '
- . Gating unit was redesigned to improve the making triggers for sequence.
Mentions image processing
The computer only for reconstruction was carried for high-speed image processing.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
The 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
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): 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
ਤੇ ਨੇ ।।
5 2002 NOV
Appendix 1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. DEVICE NAME: | Magnetic Resonance Diagnostic Device Accessory |
|---|---|
| Model Name: | MRT-1501/P3,P2 |
| Trade/Proprietary Name: | EXCELART™ with Pianissimo XG/AG SPIN Edition |
| 2. ESTABLISHMENT REGISTRATION: | 2020563 |
| 3. U.S. Agent Name and Address: | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| 2441 MICHELLE DRIVE | |
| TUSTIN, CA 92780 | |
| Contact Person: | Michaela Mahl |
| (714) 730 - 5000 | |
| 4. Manufacturing Site: | TOSHIBA CORPORATION |
| MEDICAL SYSTEMS COMPANY | |
| 1385 Shimoishigami | |
| Otawara-shi, Tochigi 324-8550, Japan | |
| 5. DATE OF SUBMISSION: | September 27, 2002 |
DEVICE DESCRIPTION 6.
The EXCELART™ with Pianissimo XG/AG SPIN Edition system has the following features compared to the current EXCELART™ with Pianissimo XG/AG system.
- Extension of a receiving system is enabled a maximum of 8 ch. .
- Use of QD Torso SPEEDER corresponding to Parallel imaging which can shorten scan time is . enabled.
- The computer only for reconstruction was carried for high-speed image processing. .
- . dB/dt enabled use by 1st operating mode specified in IEC 60601-2-33 by the TrueSSFP sequence.
- Max. field strength is changed 25mT/m to 30mT/m. .
- . The marginal performance (Min.TR/Min.TE / Min.Slice thickness / Imaging area) of a sequence has been improved.
- The user interface of software was changed for the improvement of operativity. '
- . Gating unit was redesigned to improve the making triggers for sequence.
| Model Number with suffix | Trade/Proprietary Name |
|---|---|
| MRT-1501/P3 | EXCELART TM with Pianissimo XG SPIN Edition |
| MRT-1501/P2 | EXCELART TM with Pianissimo AG SPIN Edition |
1
SUMMARY OF MAJOR HARDWARE CHANGES 6.1.
A. The computer only for reconstruction was carried for high-speed image processing.
- B. Gating unit was redesigned to improve the making triggers for sequence.
C: 8ch phased array kit is added in the optional items.
D. 70mm Circular coil is added in the optional items.
E. QD torso SPEEDER is added in the optional items.
F. QD Neurovascular array coil (K001870) is added in the optional items.
SUMMARY OF MAJOR SOFTWARE CHANGES 6.2.
A. Improved user interface.
- B. New RF coils control.
- C. dB/dt limitation control.
- D. True Steady State Free Precession (SSFP) sequence.
- E. Parallel imaging.
7. SAFETY PARAMETERS
| | Current EXCELART™ with
Pianissimo XG/AG (No changes
from the previous submission,
K002531) | New EXCELART™
with Pianissimo
XG/AG SPIN Edition |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| a. Static field strength: | 1.5 T | Same |
| b. Peak and A-weighted acoustic
noise: | 95.0 dB(A-weighted) | 95.4 dB(A-weighted) |
| c. Operational modes: | Normal operating mode | 1st operating mode for
dB/dt |
| i. Safety parameter display: | SAR | SAR, dB/dt |
| ii. Operating mode access
requirements: | Not applicable because used
only in normal operating mode | Same |
| d. Maximum SAR |