(63 days)
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).