(174 days)
No
The summary does not mention AI, DNN, or ML, nor does it describe any training or test sets typically associated with AI/ML development. The focus is on software upgrades and new imaging sequences.
No
The described device is used for imaging, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as an upgrade to existing MRI systems (FLEXART and VISART) and its Intended Use / Indications for Use section clearly states "Imaging of: The Whole Body..." for various anatomical sites and imaging techniques (e.g., MRCP, MR Angiography). MRI is an imaging modality used for diagnostic purposes, and the output (images) is used by healthcare professionals to diagnose conditions.
No
The device is described as a software upgrade to existing Magnetic Resonance Imaging (MRI) systems (MRT-50GP/E2, MRT-50GP/H2, MRT-150/F1, MRT-150/F2). While it is a software component, it is explicitly tied to and functions as part of a larger hardware system (the MRI scanner) and is not a standalone 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 describes imaging of various parts of the body using Magnetic Resonance (MR). This is a diagnostic imaging technique performed in vivo (within the living body), not in vitro (outside the body, typically on biological samples).
- Device Description: The device is a software upgrade for existing MR imaging systems. MR systems are used for diagnostic imaging, not for testing biological samples.
- Lack of IVD Indicators: There are no mentions of analyzing biological samples, performing tests on bodily fluids or tissues, or providing results related to the chemical, biological, or immunological state of a patient's sample.
The information clearly points to a medical imaging device used for diagnostic purposes on the patient, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Imaging of: The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs and extremities). [Application terms include MRCP (MR Cholangiopancreatography), 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
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
This submission consists of a software upgrade to the MRT-50GP/E2 (FLEXARTTM), MRT-50GP/H2 (FLEXARTTM/Hyper), MRT-150/F1 (VISARTTM), MRT-150/F2 (VISARTTM/Hyper)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head, body, extremity, spine, neck, TMJ, and heart
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)
Sample clinical images are presented for new sequences.
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
K98 3110
510(k) Premarket Notification
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. | DEVICE NAME:
Model Number: | Magnetic Resonance Diagnostic Device Accessory
MRT-50GP /E2 (FLEXARTTM), /H2 (FLEXARTTM/Hyper)
MRT-150 /F1 (VISARTTM), /F2 (VISARTTM/Hyper) | | |
|----------------------------------------------------|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------|
| | Trade/Proprietary Name: | FLEXARTTM, FLEXARTTM/Hyper, VISARTTM,
VISARTTM/Hyper | | |
| 2. | ESTABLISHMENT REGISTRATION: | 2636923 | | |
| 3. | U.S. AGENT NAME AND ADDRESS: | Toshiba America MRI, Inc.
280 Utah Avenue
South San Francisco, CA 94080 | | |
| | CONTACT PERSON: | Ken Nehmer
(650)872-2722 ext. 6083 | | |
| 4. | MANUFACTURING SITE: | Toshiba Corporation
1385 Shimoisigami
Otawara-shi, Tochigi-Ken
Japan 324 | | |
| 5. | DATE OF SUBMISSION: | September 1, 1998 | | |
| 6. | DEVICE DESCRIPTION: | This submission consists of a software upgrade to the MRT-
50GP/E2 (FLEXARTTM), MRT-50GP/H2 (FLEXARTTM/Hyper),
MRT-150/F1 (VISARTTM), MRT-150/F2 (VISARTTM/Hyper) | | |
| 7. | SAFETY PARAMETERS:
Maximum static field strength: | FLEXARTTM &
FLEXARTTM/Hyper | V3.5 s/w
0.5 T | V4.0 s/w
0.5 T |
| | | VISARTTM &
VISARTTM/Hyper | 1.5T | 1.5T |
| | Rate of change of magnetic field: | FLEXARTTM
FLEXARTTM/Hyper | 11 T/sec.
13.3 T/sec. | 11 T/sec.
13.3 T/sec. |
| | | VISARTTM
VISARTTM/Hyper | 13.3 T/sec.
19.5 T/sec. | 13.3 T/sec.
19.5 T/sec. |
| Maximum radio frequency power
deposition (SAR): | | V3.5 s/w | V4.0 s/w | |
| FLEXART™ &
FLEXART™/Hyper | |