(130 days)
Change Healthcare Stratus Imaging PACS is a software-based medical image management and processing system intended to process and display medical images for the purposes of diagnostic viewing and interpretation by qualified and trained healthcare professionals, including, but not restricted to, radiologists and non-radiology physicians.
The Diagnostic Viewer of Change Healthcare Stratus Imaging PACS provides medical image postprocessing functions such as image manipulation and enhancement that are intended for use in the clinical image review and analysis of medical images acquired through DICOM-compliant imaging devices or IT interfaces.
Change Healthcare Stratus Imaging PACS can be used as a full-featured medical image management and processing system or as an independent viewer in clinical settings.
Only uncompressed or non-lossy compressed DICOM images can be used for primary image diagnosis and interpretation for mammography using monitors intended for mammography display and cleared by the requlatory authority in your region or jurisdiction.
Change Healthcare Stratus Imaging PACS is not intended for diagnostic use on mobile devices.
Change Healthcare Stratus Imaging PACS is a software-based medical image management and processing system designed to perform the necessary functions required for diagnosis and interpretation of medical information. It is intended to be used by qualified and trained radiology physicians for the purpose of assisting in diagnosis and interpretation of medical images.
Change Healthcare Stratus Imaging PACS provides users with a zero-footprint, browser-based diagnostic viewer capable of directly displaying diagnostic quality DICOM standard images, reports and discrete data information acquired by various data sources. The diagnostic viewer provides users with tools and features, including measurement, annotations, comparison, and digital processing of medical images, such as image manipulation, enhancement, and 3D/4D visualization.
Change Healthcare Stratus Imaging PACS functionality, such as storage, import, sharing, retrieval, and display, that supports the day-to-day operations of qualified and trained healthcare professionals, such as technologists and PACS administrators.
Change Healthcare Stratus Imaging PACS uses a cloud-based architecture offering zero-footprint deployment in hospitals, clinics imaging centers and other healthes. Authorized users from both clinical facilities and remote locations can directly access Change Healthcare Stratus Imaging PACS.
Change Healthcare Stratus Imaging PACS operates on approved web browsers running on commercially available hardware that meets approved specifications.
Change Healthcare Stratus Imaging PACS is designed to integrate with third party, off-the-shelf software through Application Programming Interfaces (APIs) and supported standards (for example, HL7, DICOM) to allow connectivity with systems used in the clinical environment such as reporting tools, EMRs, and advanced visualization tools.
This document (K241981) describes a 510(k) submission for the Change Healthcare Stratus Imaging PACS device, which is a software-based medical image management and processing system. However, it explicitly states on page 6 that "Non-clinical tests, such as mechanical engineering performance testing, are not applicable to the subject device, as Change Healthcare Stratus Imaging PACS is software-only device (SaMD)."
Furthermore, the document states: "Software verification and validation were completed to ensure that the features conformed to all new and previously defined specifications and any risks were properly mitigated, and that the modifications did not degrade the existing functionality. All the software specifications have met the acceptance criteria and the software ad all product release criteria. The testing results did not raise new or different questions of safety and effectiveness other than those already associated with the predicate device."
This indicates that software verification and validation were performed against internal specifications and product release criteria. The document does NOT describe a study that uses a test set with ground truth established by experts to prove the device meets specific acceptance criteria in terms of clinical performance (e.g., diagnostic accuracy, sensitivity, specificity). It focuses on substantial equivalence to a predicate device (K203249) and validation of software functionality rather than a clinical performance study.
Therefore, I cannot provide the requested information from the provided text, as the document does not contain details of such a study.
§ 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).