Search Results

The MDV-PACS device is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards.

The MDV-PACS device is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards.

The provided text is a 510(k) clearance letter from the FDA for the "DVNET MDV-PACS" device, a Picture archiving and communication system (PACS). This document does not contain information regarding acceptance criteria, specific studies, sample sizes, expert qualifications, or ground truth establishment for performance evaluation.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to a predicate device, not necessarily on a performance study that measures specific acceptance criteria against reported device performance as would be required for a novel device or a device making new performance claims.

Therefore, I cannot provide the requested information from the given text. A 510(k) summary or a more detailed submission document would be required to find such details.

Ask a specific question about this device