Search Results

The software, when installed on PC-based system, enables the medical professional to read cardiac patient exam records from pre-recorded, transferable media (i.e., CD-R), magnetic hard disc drives and networks. The software enables motion to be viewed at speeds of up to 60 frames per second, at slow speeds and of both still and dynamic still frames. The software enables the printing of still frames as well as the export of images, especially when appropriate.

Not Found

I am sorry, but the provided text, which appears to be an FDA 510(k) clearance letter for the "Kodak Digital Science Cardiac Viewer," does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document is primarily a formal notification of substantial equivalence to a predicate device, allowing the manufacturer to market the product. It outlines regulatory information, general controls, and the intended use of the device, but it does not delve into the specific technical performance studies or the results of such studies.

Therefore, I cannot populate the requested table or answer the specific questions based on the provided text.

Ask a specific question about this device