(101 days)
UniWeb™ 8.0 is a device that receives digital images and data from various sources (including but not limited to Fullfield digital mammography, MR scanners, CR, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other DICOM formatted imaging sources).Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations.
UniWeb™ 8.0 is utilized only on FDA cleared monitors for interpretation of mammography images in a primary diagnostic setting. Moreover, it can display FFDM(Full-field digital mammography) post-processed images in DICOM for presentation only formats. This device will only use lossless compression when displaying mammography images. For image diagnosis, this device can only be used by trained professionals. However, for image review, the users will not be limited to physicians, nurses and technicians.
UniWeb™ 8.0 is a device that receives digital images and data from various sources (including but not limited to Fullfield digital mammography, MR scanners, CR, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other DICOM formatted imaging sources).Images and data can be stored, communicated, processed and displayed within the system and or across a computer network at distributed locations.
The provided text is a 510(k) clearance letter for a Picture Archiving and Communication System (PACS) device, UniWeb™ 8.0. This document focuses on regulatory approval based on substantial equivalence to existing devices and outlines the indications for use. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance from the provided document. The letter is a communication from the FDA granting clearance, not a technical report detailing performance studies.
§ 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).