(75 days)
Ultrapro is a system that utilizes standard personal computer hardware to acquire, display, communicate and archive diagnostic images. The system is designed for use by medical professionals to acquire data from FDA listed imaging equipment such as ultrasound, CT and MRJ scanners, x-ray imagers and video cassette recorders that provide a video output or a digital output. Archival is to be performed on media that is FDA listed.
Ultrapro can be configured to use JPEG lossy compression. When lossy compression is used, the compression ratio will be imprinted in the non-diagnostic area of the image. The compression ratio can be adjusted during acquisition.
Ultrapro is a tool for a medical imaging practice. It can acquire medical images from any standard medical video source. Digital data in the DICOM format or other popular PC formats such as JPEG, TIFF, etc. can also be acquired.
Images may be acquired in uncompressed or compressed format (lossless or lossy). The lossy compression ratio is selected by viewing the original image and the lossy compressed image side by side and increasing the ratio while retaining clinically significant characteristics. Images that have been lossy compressed have the text "LOSSY xx:1" where xx is the compression ratio placed in the visible, non-diagnostic area of the image.
Related patient information can also be entered or scanned in with a TWAIN compliant scanner. Once acquired, Ultrapro serves as a digital storage for these images. Images are stored on the computer. Images may be communicated to other Ultrapro workstations or to third-party DICOM 3.0 compliant PACS components. The radiologist may review the images with Ultrapro and create reports. The display of images (contrast, brightness, zoom, etc.) may be adjusted at any time. Annotations may be drawn on images. Distance measurements may be made on images. These image parameters may be saved along with the image while still preserving the original image. This information can be communicated to other workstations through a network or modem. Finally, all of the information may be archived onto optical media for permanent storage.
The provided text is a 510(k) Summary for the "Ultrapro 98" Picture Archiving and Communication System (PACS) from RamSoft Inc. It focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or specific studies proving device performance against those criteria. The document explicitly states:
"The determination of substantial equivalence is not based on an assessment of performance tests."
Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies from this document. The sections you asked about are not present in the provided 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).