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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.

Not Found

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.

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