(46 days)
To be used in conjunction with a Magnetic Resonance Scanner to:
-
- Produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.
-
- Permit MR-quided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.
Model BBC-127 Biopsy Breast Coil
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a "Model BBC-127 Biopsy Breast Coil" and primarily addresses the regulatory approval process and indications for use.
Therefore, I cannot provide the requested information about acceptance criteria or a study from this document.
§ 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.