(89 days)
No
The document describes software modifications and new sequences for an existing MR imaging system, focusing on image acquisition and reconstruction. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML applications.
No
The device is described as facilitating the acquisition and reconstruction of MR images for diagnostic purposes, not for treating conditions.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is for "Imaging of: The Whole Body," and lists various applications like "MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography," which are diagnostic imaging procedures. The "Device Description" also mentions facilitating the "acquisition and reconstruction of MR images," which are integral to diagnostic imaging.
No
The device is described as software that facilitates the acquisition and reconstruction of MR images, implying it is part of a larger MR imaging system which includes hardware. The predicate devices also include hardware components like coils, monitors, and beds.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes imaging of various parts of the body using Magnetic Resonance (MR). This is an in-vivo imaging technique, meaning it is performed on a living organism.
- Device Description: The device is described as software that facilitates the acquisition and reconstruction of MR images. This aligns with an in-vivo imaging system.
- Input Imaging Modality: The input modality is Magnetic Resonance, which is an in-vivo imaging technique.
- Anatomical Site: The anatomical sites listed are parts of the human body, consistent with in-vivo imaging.
In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (such as blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
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
Additional indications for v3.1, v3.2, & v3.3 (only)
-
MR Angiography/MR Vascular Imaging -
Additional indication for v3.2 & v3.3 (only) -
Water/Fat Imaging -
Additional indication for v3.3 {only}
Perfusion/Diffusion Imaging -
Product codes
90 LNH, 90 MOS
Device Description
Versions v3.0/v3.1/v3.2/v3.3 software are a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images. The four versions have the same base software features with certain additional features available in each subsequent version (see Comparison Table, Appendix B, for detailed description). A brief description follows:
- v3.0: Based on v2.5 (K990260) with MR Angio and FASE sequences removed
- v3.1: Based on v2.5 (K990260)
- v3.2: Based on v2.6 (K990260)
- v3.3: Based on v2.6 (K990260) with addition of Perfusion/Diffusion imaging
A brief summary of the new software functionality is described below:
6.1 DESCRIPTION OF NEW SOFTWARE FUNCTIONALITY (v3.0/v3.1/v3.2/v3.3)
- Increase in software limit of SAR from
§ 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
510(k) Premarket Notification
SUMMARY OF SAFETY AND EFFECTIVENESS
-
DEVICE NAME: Magnetic Resonance Diagnostic Device Accessory 1. MRT-600 Model Number: Trade/Proprietary Name: OPART™ including: OPART™/Prodiga, (v3.0 & manual bed) OPART™/Potenza (v3.2 & motorized bed) OPART™/Paragon (v3.3, motorized bed, & array electronics) 2636923 2. ESTABLISHMENT REGISTRATION: 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 America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080 DATE OF SUBMISSION: October 19, 1999 5. 6. DEVICE DESCRIPTION: Versions v3.0/v3.1/v3.2/v3.3 software are a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images. The four versions have the same base software features with certain additional features available in each subsequent version (see
Comparison Table, Appendix B, for detailed description). A brief description follows: -
v3.0: Based on v2.5 (K990260) with MR Angio and FASE sequences removed
-
v3.1: Based on v2.5 (K990260)
-
v3.2: Based on v2.6 (K990260)
-
v3.3: Based on v2.6 (K990260) with addition of Perfusion/Diffusion imaging
A brief summary of the new software functionality is described below:
6.1 DESCRIPTION OF NEW SOFTWARE FUNCTIONALITY (v3.0/v3.1/v3.2/v3.3) এ.
- Increase in software limit of SAR from