(177 days)
The MRI ECG Patient Cable is intended to connect electrodes placed on a patient to a host device. The cable is intended for use in up to 3.0T in MRI environments. It is used in a professional healthcare facility environment.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (MRI ECG Patient Cable). This letter does not contain any information about acceptance criteria, study details, performance data, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the given document. The letter only states that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls.
§ 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.