(14 days)
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No
The document describes a standard MRI system with hardware and software enhancements, but there is no mention of AI or ML in the intended use, device description, or any other section. The modifications listed are related to hardware components and general system performance.
No
The intended use of the device is for 'Imaging' and it is described as a 'Magnetic Resonance Imaging (MRI) System', which is a diagnostic tool, not a therapeutic one.
Yes
The device is an MRI system explicitly used for "Imaging" of various body parts and fluid visualization, which are diagnostic procedures. The "Intended Use / Indications for Use" section lists multiple applications like MRCP, MR Urography, MR Myelography, and Spectroscopy, all aimed at diagnosing medical conditions.
No
The device description explicitly states it is a "1.5 tesla Magnetic Resonance Imaging (MRI) System" and details hardware components like a magnet, bore, patient couch, and RF coils. This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states this is a Magnetic Resonance Imaging (MRI) system. Its intended use is for imaging the human body and its structures. MRI is an in vivo imaging modality, meaning it takes images of the body from the outside, without requiring samples to be taken.
The information provided focuses on the technical specifications of the MRI machine and the types of imaging sequences it can perform, all of which are characteristic of an imaging device, not an IVD.
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 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)
LNH
Device Description
The EXCELART Vantage Atlas is a 1.5 tesla Magnetic Resonance Imaging (MRI) System. The Atlas has a 1.4 m short magnet (55 cm field of view) and includes Toshiba's Pianissimo™ technology (scan noise reduction technology). The wide bore has a 655 mm opening.
There are two models in the EXCELART Vantage Atlas line as follows:
- EXCELART Vantage Atlas-Z Model No. MRT-1503/S3
- EXCELART Vantage Atlas-X Model No. MRT-1503/S3
The EXCELART Vantage Atlas MRI System is comparable to the EXCELART Vantage ZGV MRI System (K060003, cleared January 18, 2006) with the following modifications:
- . 16 Channel phased array system control
- . CPU performance of the computer system has been enhanced
- The longitudinal movement of the patient couch has been increased
- . Additional table top coil ports
- . Additional RF coils – Atlas SPEEDER Head, Atlas SPEEDER Spine, and Atlas SPEEDER Body)
- SAR limit is 4 W/kg for whole body in conformance with IEC 60601-2-33 (2002)
Mentions image processing
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Mentions AI, DNN, or ML
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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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
K06336/
510(k) Premarket No Excelart Vantage™ Atlas Z, Atlas X
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
NOV 2 1 2006
| 1. Device Name | Magnetic Resonance Diagnostic Device Accessor | |
|---|---|---|
| Model Name: | MRT 1503/S5, MRT-1503/S3 | |
| Trade/Proprietary Name | EXCELART Vantage Atlas-Z, Atlas-X | |
| 2. Establishment Registration No.: | 2020563 | |
| 3. U.S Agent Name and Address: | Toshiba America Medical Systems, Inc. | |
| 2441 Michelle Drive | ||
| Tustin, CA 92780 | ||
| Contact Person: | Paul Biggins | |
| (714) 730-5000 | ||
| 4. Manufacturing Site: | Toshiba Corporation | |
| Medical Systems Company | ||
| 1385 Shimoishigami | ||
| Otawara-shi, Tochigi 32408550, Japan | ||
| 5. Date of Submission: | November 1, 2006 |
6. DEVICE DESCRIPTION
The EXCELART Vantage Atlas is a 1.5 tesla Magnetic Resonance Imaging (MRI) System. The Atlas has a 1.4 m short magnet (55 cm field of view) and includes Toshiba's Pianissimo™ technology (scan noise reduction technology). The wide bore has a 655 mm opening.
There are two models in the EXCELART Vantage Atlas line as follows:
| • EXCELART Vantage Atlas-Z | Model No. MRT-1503/S3 |
|---|---|
| • EXCELART Vantage Atlas-X | Model No. MRT-1503/S3 |
The EXCELART Vantage Atlas MRI System is comparable to the EXCELART Vantage ZGV MRI System (K060003, cleared January 18, 2006) with the following modifications:
- . 16 Channel phased array system control
- . CPU performance of the computer system has been enhanced
- The longitudinal movement of the patient couch has been increased
- . Additional table top coil ports
- . Additional RF coils – Atlas SPEEDER Head, Atlas SPEEDER Spine, and Atlas SPEEDER Body)
- SAR limit is 4 W/kg for whole body in conformance with IEC 60601-2-33 (2002)
1
6.1. Summary Of Major Hardware Changes
- a. Maximum supported phased array channel has been increased from 8 to 16.
- b. CPU performance of computer system has been enhanced.
- c. Patient couch longitudinal movement has been increased.
- d. Table top coil ports have been added.
- e. Atlas SPEEDER Head and Atlas SPEEDER Spine and Atlas SPEEDER Body are added to the available coil list.
6.2. Summary Of Major Software Changes
- a. 16 channel phased array system control.
- b. New CPU correspondence.
- c. New patient couch control.
- d. New RF coil control.
- e. SAR limitation control.
7. SAFETY PARAMETERS
| | Current EXCELART Vantage™
ZGV (No changes from the
previous submission, K060003 ) | New EXCELART
Vantage
Atlas-Z/Atlas-X |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| 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 and
SAR | Same |
| i. Safety Parameter Display: | SAR, dB/dt | Same |
| ii. Operating mode access
requirements: | Allows access to 1st level operating
mode | Same |
| d. Maximum SAR | 3W/kg for whole body (1st
operating mode specified in IEC
60601-2-33 (2002)) | 4W/kg for whole body
(1st operating mode
specified in IEC
60601-2-33 (2002)) |
| e. Maximum dB/dt and Gradient
Coil Dimensions: |