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The 2D and 3D Magnetic Resonance Imaging and Proton Spectroscopy of the anatomy of head and brain. This device is used in association with a General Electric 1.5T Signa MRI System and is currently cleared for use with the PROBE (Proton Brain Exam) option.

Special Procedures II Head Coil, Model #1400GE-64

I am sorry, but based on the provided text, I cannot provide details on the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a medical device (Special Procedures II Head Coil, Model #1400GE-64).

This letter primarily focuses on:

• Substantial Equivalence Determination: The FDA's finding that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Information: The device's regulation number, regulation name, regulatory class, and product code.
• General Controls: Information about the general controls provisions of the Act (registration, listing, GMP, labeling, misbranding, adulteration).
• Contact Information: For specific advice on labeling regulations.
• Indications for Use: A brief statement outlining what the device is intended for.

The letter explicitly states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

The acceptance criteria and detailed study data (including specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) are generally part of the 510(k) submission itself, which is not fully provided in these excerpts. The letter only confirms that such a submission was reviewed and deemed acceptable for market clearance based on substantial equivalence to a predicate device. It does not contain the detailed study results or explicit acceptance criteria.

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