AspenView
Aspen Imaging Healthcare IncAspenView is a software designed to assist radiologists and radiology technicians in annotating, processing, and managing general radiographic X-ray images. It supports standard medical image formats and provides functions such as image stitching, storage, and transmission, helping clinicians handle and review X-ray images efficiently.
Intended Use
AspenView is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications). The main features of this software are storing acquired images, data management, image processing and image stitching.
Technology
AspenView software is designed to digitize signals from an X-ray detector, enabling annotation of images. It supports DICOM 3.0 standard and other formats like TIFF and RAW. The software includes image stitching to combine multiple images into one image based on overlapping areas, image retrieval, storage, and transmission functions. It interfaces with Aspen Imaging Flat Panel DR Detector and Aspen Imaging Healthcare Image Viewer.
Performance
Safety and software verification and validation testing was performed according to IEEE 1012-2012 standards. Cybersecurity information and software validation comply with FDA guidance for premarket software submissions and cybersecurity in medical devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/20/2024
8 months - 2
FDA Approval
2/12/2025
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