(77 days)
The MRI PPG Patient Cable is intended to connect to a parent device and facilitate the generation of continuous noninvasive peripheral pulse cardiac gating on adult, pediatric, and neonatal patients in hospital and/or health care environments.
Not Found
The provided document is a 510(k) clearance letter for the "MRI PPG Patient Cable" and contains "Indications for Use" information. It does not include details on acceptance criteria or a study proving that the device meets such criteria.
The information provided describes the device's intended use and regulatory classification, but it does not delve into its performance metrics, how those metrics were evaluated, or any studies conducted to validate its performance against specific acceptance criteria.
Therefore, I cannot provide the requested information based on the given text. The document focuses on regulatory clearance rather than technical performance validation.
§ 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.