(63 days)
The 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head. This device is used in conjunction with a General Electric 1.5 Tesla MRI Scanner and for Spectroscopy will need the addition of the PROBE (Proton Brain Exam) software option.
Brain Coil, Model # 9900GE-64
This document is a 510(k) premarket notification from the FDA for a medical device. It does NOT contain the acceptance criteria, reported device performance, or study details requested.
The document is a letter from the FDA to Clinical MR Solutions, LLC, confirming the substantial equivalence of their "Brain Coil, Model # 9900GE-64" to legally marketed predicate devices. It states that the device is a Magnetic Resonance Diagnostic Device (21 CFR 892.1000, Regulatory Class II).
The "Indications for Use" section (Attachment 3) describes what the device is intended for:
- 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the Brain and anatomy of the head.
- It is used in conjunction with a General Electric 1.5 Tesla MRI Scanner.
- For Spectroscopy, it requires the addition of the PROBE (Proton Brain Exam) software option.
Therefore, I cannot provide the requested information from this document. This document focuses on regulatory approval based on substantial equivalence, not on specific performance studies or acceptance criteria for a new AI/software device. It predates the widespread use of AI in medical devices by many years (2003).
§ 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.