Search Results

It is intended to be used in the heart and mediastinum regions for 2D and 3D Magnetic Resonance imaging.

The 8 Channel Cardiac Phased Array Coil is a modification to the Cardiac Phased Array Coil (K971667), which utilizes an increase in the number of independent receive channels from four to eight, integrates preamplifiers, and utilizes ASSET optimized geometry.

The provided text describes a 510(k) submission for the "8 Channel Cardiac Phased Array Coil" by GE Medical Systems. While it states that "Testing was performed to demonstrate that the design modifications to the 8 Channel Cardiac Phased Array Coil meet predetermined acceptance criteria," the document does not elaborate on what those specific acceptance criteria were or detail the study that proved the device met them.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the provided text.

The document focuses on demonstrating substantial equivalence to predicate devices (GE Cardiac Phased Array Coil K971667 and MRI Devices Corporation HRH-63-8 Head Array Coil K013159) based on design modifications such as:

• Increase in independent receive channels from four to eight.
• Integration of preamplifiers.
• Optimization for ASSET applications.

The only statement related to performance or testing is very general.

Ask a specific question about this device