BBC-63-GE BREAST ARRAY COIL

• K Number: K023164
• Device Name: BBC-63-GE BREAST ARRAY COIL
• Manufacturer: MRI DEVICES CORP.
• Date Cleared: 2002-10-11 ( 18 days)
• Product Code: MOS
• Regulation Number: 892.1000
• Type: Special
• Panel: RA
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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.

Device Description

Model BBC-63-GE Breast Array Coil

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the "Model BBC-63-GE Breast Array Coil." This document does not contain any information about acceptance criteria, device performance metrics, or details of a study used to prove the device meets acceptance criteria.

The letter primarily:

• Confirms the device (a breast array coil for MRI) has been found substantially equivalent to a legally marketed predicate device.
• States the device's indications for use (to produce diagnostic images of the female breast, chest wall, and axillary tissues).
• Outlines post-market regulatory requirements for the manufacturer.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The requested information would typically be found in the 510(k) submission itself (specifically in sections detailing performance data and clinical/non-clinical studies), not in the clearance letter.

Regulation Number and Section

§ 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.