(60 days)
The Hologic SecurView DX device is intended for selection, display, manipulation, filming and media interchange of multi-modality images from a variety of different storage and printing devices using DICOM or similar interface standards.
The device used with FDA cleared monitors may be used by a trained physician for display, manipulation and interpretation of lossless and on non-compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image.
The Hologic SecurView DX is mainly a software product. It is used for visualization and processing of radiology images. The SecurView DX is a multi-modality review workstation. It includes two high-resolution gray scale monitors (FDA cleared for Mammography), 3-button mouse, keyboard and workstation keypad. The software accepts images which have occurred. Image processing is external to the Presentation Specification in the DICOM Standard and the system allows for no compression at all when displaying mammography images.
The minimum computer requirements are:
Windows 2000® Operating System
Intel CPU with a clock rate of 2.0 GHz or greater
2.0 GB RAM or greater
140 GB Hard drive or greater, operating at 160 Mbs or greater
CD-ROM/R/RW, DVD+/-RW
10/100 Base TX Network Interface
The provided text is a 510(k) summary for the SecurView DX product. It describes the device's intended use and general information but does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications necessary to answer your request.
The document is primarily a regulatory filing from the FDA, confirming the clearance of the device based on substantial equivalence to a predicate device. It details product classification, contact information, and indications for use.
Therefore, I cannot provide the requested table and information based on the input text.
§ 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).