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K Number
K032576
Device Name
BIOPSY BREAST COIL, MODEL BBC
Manufacturer
MRI DEVICES CORP.
Date Cleared
2003-10-23

(64 days)

Product Code
MOS
Regulation Number
892.1000
Type
Special
Panel
RA
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To be used in conjunction with a Magnetic Resonance Scanner to:

  1. Produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.
  2. Permit MR-guided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification clearance letter from the FDA for a device called "Biopsy Breast Coil BBC," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The document includes:

  • Device Name: Biopsy Breast Coil BBC
  • Regulation Number: 21 CFR 892.1000 (Magnetic resonance diagnostic device)
  • Regulatory Class: II
  • Product Code: 90 MOS
  • Indications for Use:
    1. To produce diagnostic images of the female breast, chest wall, and axillary tissues that can be interpreted by a trained physician.
    2. To permit MR-guided breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.

However, there is no information regarding specific acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. This letter is a regulatory approval, not a scientific study report.

§ 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.