Search Results

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 .

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 MR images. This software will function on both SGI Indigo 2 and O2 computer workstations. The V2.6 software may also be identified as Performance Plus option.

The provided document is a 510(k) Premarket Notification for a diagnostic magnetic resonance device (OPART™ version 2.5/2.6 software for MRT-600) from 1999. It focuses on the safety and imaging performance parameters of the MR system and its software updates. It does not contain information related to a clinical study with acceptance criteria for a device's diagnostic performance, nor does it describe a study involving human readers, ground truth establishment, or multi-reader multi-case analysis as typically seen for AI/CAD devices.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated based on the document:

1. A table of acceptance criteria and the reported device performance

The document lists "Safety Parameters" and "Imaging Performance Parameters" which function as specifications for the device. These are accepted as meeting the requirements for substantial equivalence.

Ask a specific question about this device