(86 days)
PACSPLUS™ is a device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
PACSPLUS™ makes possible the capturing, storage, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to PACSPLUS™, the system can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation.
This document is a 510(k) summary for a Picture Archiving Communications System (PACS) called PACSPLUS™. The document describes the device's indications for use and states that it has been determined substantially equivalent to a predicate device. However, this document does not contain information regarding acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about the training data.
The document focuses on the regulatory aspects of the device, primarily establishing its substantial equivalence to an existing product (MAROSIS™ PACS). It lists the device's ability to capture, store, distribute, and network medical images, and its intended users (trained professionals like physicians, nurses, and technicians).
Therefore, I cannot provide the requested table and information as the provided text does not contain these details. The 510(k) process for this type of device typically focuses on technical characteristics and intended use compared to a predicate, rather than detailed clinical performance studies with specific statistical endpoints like those requested in your prompt.
§ 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).