(78 days)
No
The document describes software modifications for image acquisition and reconstruction, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML models.
No
The device is described as software that facilitates the acquisition and reconstruction of MR images for diagnostic imaging purposes, not for treating any condition. Its intended use is imaging of various body parts and fluid visualization, aligning with diagnostic rather than therapeutic functions.
Yes
The device's function is to facilitate the acquisition and reconstruction of MR images for "imaging of" various anatomical sites, and a predicate device (K981475) is explicitly identified as a "diagnostic resonance system."
No
The device is described as software that functions on specific computer workstations (SGI Indigo 2 and O2). While the submission focuses on software modifications and enhancements, the device description explicitly mentions the need for these software versions to function on specific hardware platforms, implying it is not purely software independent of dedicated hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is software for Magnetic Resonance (MR) imaging. MR imaging is a non-invasive technique that uses magnetic fields and radio waves to create images of the inside of the body. It does not involve testing samples taken from the body.
- Intended Use: The intended use is for "Imaging of: The Whole Body..." and lists various anatomical sites and imaging applications. This is consistent with the function of an MR imaging system, not an IVD.
- Device Description: The description focuses on software modifications and enhancements for acquiring and reconstructing MR images.
- Performance Studies: The performance studies mentioned involve "Sample phantom images and clinical images," which are typical for evaluating the image quality and performance of an MR system. There is no mention of evaluating the accuracy of detecting substances or conditions in biological 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, breast, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR neok, Ywis, Hoard Broomy), 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
Product codes
90 LNH
Device Description
Version 2.5/V2.6 software is a combination of modifications and the enhancement of sequences to the existing software, which facilitate the acquisition and reconstruction of This software will function on both SGI Indigo 2 and O2 computer MR images. workstations. The V2.6 software may also be identified as Performance Plus option.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head, body, extremity, spine, neck, TMJ, breast 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 phantom images and clinical images are presented for all new sequences, demonstrating conformance with consensus standards requirements for Signal-to-Noise ratio, Uniformity, Slice Profiles, Geometric Distortion, and Slice Thickness/Interslice Spacing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APH 1 3
510(k) Premarket Notification
Summary of Safety and Effectiveness
- Magnetic Resonance Diagnostic Device 1. DEVICE NAME: Accessorv MRT - 600 Model Number: OPART™ Trade/Proprietary Name: 293623 2. ESTABLISHMENT REGISTRATION: Toshiba America MRI. Inc. 3. U.S. AGENT Name and Address: 280 Utah Avenue South San Francisco, CA 94080 Bruce Clark Contact Person: (650) 742-6068 Toshiba America MRI, Inc. 4. Manufacturing Site: 280 Utah Avenue South San Francisco, CA 94080 January 25, 1999 5. Date of Submission:
6. DEVICE DESCRIPTION:
Version 2.5/V2.6 software is a combination of modifications and the enhancement of sequences to the existing software, which facilitate the acquisition and reconstruction of This software will function on both SGI Indigo 2 and O2 computer MR images. workstations. The V2.6 software may also be identified as Performance Plus option.
7. SAFETY PARAMETERS:
| Maximum static field strength: | 0.35 Tesla |
|---|---|
| Rate of change of magnetic field: | 19T/second |
| Maximum radio frequency power deposition (SAR): |