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To be used in conjunction with a 1.5T GE HD or DV series Magnetic Resonance Scanner to produce diagnostic images of the upper and lower extremities, head, neck and spine that can be interpreted by a trained physician.

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The provided text is a set of FDA letters regarding a 510(k) premarket notification for a medical device called "MetaFlexCoil," and an "Indications for Use" statement.

This document describes the regulatory approval of a medical device, specifically a "Magnetic resonance diagnostic device" (Product Code MOS) called "MetaFlexCoil." It does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested in the prompt. The letter only states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

Therefore, I cannot fulfill your request for information about acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval letter, not a study report or a summary of performance data.

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