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To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissues that can be interpreted by a trained physician.

Magnetic Resonance Specialty Coil, Model OBC-300 Breast Array Coil

This is a 510(k) clearance letter and an Indications for Use statement for a Magnetic Resonance Specialty Coil (Model OBC-300 Breast Array Coil). This type of document typically does not contain acceptance criteria or details about a study to prove device performance in the way a clinical trial report would.

510(k) clearances are primarily based on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. The focus is usually on comparing technical specifications and performance characteristics rather than extensive clinical efficacy studies to meet specific performance criteria against a disease.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided text.

Based on the nature of the documents, I can provide the following:

Device Description: Magnetic Resonance Specialty Coil (Model OBC-300 Breast Array Coil)
Intended Use: To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissues that can be interpreted by a trained physician.
Regulatory Class: II
Procode: 90 MOS

To answer the detailed questions, one would need to access the full 510(k) submission (K993776), which is not available in the provided snippets.

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