AspenView

AspenView is medical image management and processing software for radiologists and radiology technicians to annotate general radiographic X-ray images. It stores, retrieves, processes, and stitches acquired images, and allows doctors to print or send annotated images with patient information to other PACS systems. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.

AspenView provides image viewing, search, storage, annotation, measurement, processing, and stitching functions on Windows 10 and Windows-based operating systems. It interfaces with Aspen Imaging digital X-ray detectors and supports DICOM 3.0, TIFF, and Raw image formats. Unlike the predicate device EConsole1, AspenView does not control exposure settings, electrical adjustments, or X-ray system calibration.

IEEE 1012-2012 (Standard for System and Software Verification and Validation); ISO 14971:2019 (Risk Management); IEC 62304:2015 (Medical Device Software Lifecycle); ISO 13485:2019/AC2016 (Quality Management Systems).

AspenView and the predicate device EConsole1 share identical intended use, regulatory classification (21 CFR 892.2050, Class II), and core software functions including image viewing, storage, annotation, measurement, and processing with DICOM compliance. Both operate on digital X-ray detectors and support image stitching. The predicate additionally controlled X-ray generator settings, which AspenView removes, but this is not a material difference because AspenView still performs all the same image management and processing functions. The technological approach and operational principles are substantially equivalent.