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The VIEW COM is a Software Device intended to digitized and to communicate Cardiac and Cardiovascular Images from the Procedure Room to Local Network in DICOM Format.

Such Digitized Images will be visualized and archivied by independent DICOM entities.

The VIEW COM is a Software Device intended to digitized and to communicate Cardiac and Cardiovascular Images from the Procedure Room to Local Network in DICOM Format.

Such Digitized Images will be visualized and archivied by independent DICOM entities.

The provided document does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary for the "VIEW COM" device, which is an Image Digitizer and Communication System. It focuses on demonstrating substantial equivalence to predicate devices. Key sections explicitly state:

• "CLINICAL PERFORMANCE DATA: Not required for determination of substantial equivalence for this class of device." (Page 3 of 5)
• "CONCLUSION DRAWN FROM CLINICAL AND NONCLINICAL TEST DATA: Not required for determination of substantial equivalence for this class of device." (Page 3 of 5)

Therefore, none of the requested information regarding acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details are available in this document. The manufacturer was not required by the FDA to perform such studies for the 510(k) clearance of this particular device.

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