(81 days)
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), Dynavic Scan and Cine Imaging.] - -Fluid Visualization - ・ 2D/3D Imaging - MR Angiography/MR Vascular Imaging -
Versions 2 (V2) software is a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images.
The provided text is a summary of a 510(k) Premarket Notification for a software upgrade (Versions 2 (V2) software) for an existing Magnetic Resonance Diagnostic Device Accessory, the OPART™ (MRT-600). The submission focuses on demonstrating substantial equivalence to the previously cleared OPART™ system (K962933) and does not detail a study or specific acceptance criteria for a new device's performance.
Instead, the document asserts that the modifications and new sequences in V2 software do not "raise new questions of safety or efficacy" and do not introduce "any new indications for use." This type of submission relies on the established safety and efficacy of the predicate device, rather than requiring new performance studies with detailed acceptance criteria.
Therefore, the requested information regarding acceptance criteria and a study proving device performance cannot be extracted from the provided text because such a study was not performed or described. The submission's core argument is that the changes are minor and do not necessitate new performance data.
However, I can extract information related to the device and its intended use:
Device Information from the document:
- 1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as this is a software upgrade claiming substantial equivalence. The "acceptance criteria" here implicitly refer to maintaining the performance and safety profiles of the predicate device (OPART™ K962933).
- Reported Device Performance: The document provides "Imaging Performance Parameters" for the system, not specifically for the V2 software upgrade's new features. This suggests these are the general capabilities of the MR system.
| Parameter | Specification |
|---|---|
| Safety Parameters | |
| Maximum static field strength | 0.35 Tesla |
| Rate of change of magnetic field | 19T/second |
| Maximum radio frequency power deposition (SAR) |
§ 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.