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The Signa SP Crown Coil family provides imaging capability for the Signa SP MR System by facilitating magnetic resonance imaging of the head and extremities. These coils may also be used for dynamic (i.e., flexion of joints) magnetic resonance Imaging of the extremities.

The Signa SP Crown Coils are a group of solenoidal transmit/receive surface colls of varying dimensions that are contained in a flexible, blocompatible outer covering.

The provided text is a 510(k) summary for the GE Medical Systems Signa SP Crown Coils, submitted in 1996. This document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

It does not contain information about acceptance criteria or a study proving that the device meets those criteria because it is not a clinical study report or a performance validation report.

The 510(k) summary focuses on demonstrating substantial equivalence to existing devices based on:

• Indications for Use: Facilitating magnetic resonance imaging of the head and extremities, including dynamic imaging of extremities.
• Device Description: A group of solenoidal transmit/receive surface coils of varying dimensions, contained in a flexible, biocompatible outer covering.
• Safety: Stating that it does not pose additional potential hazards compared to previously marketed flexible transmit/receive surface coils.
• Equivalence Claim: Stating substantial equivalence to the transmit/receive flexible surface coil in the Signa SP MR System (K942604) and similarity in utility and general coil type to the 0.2T Extremity Coil (K954353).

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, etc.) from this document. This document is used for regulatory clearance based on substantial equivalence, not for detailed performance validation against specific acceptance criteria.

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