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510(k) Data Aggregation
K Number
K241981Device Name
Change Healthcare Stratus Imaging PACS
Manufacturer
Change Healthcare Canada Company
Date Cleared
2024-11-12
(130 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Change Healthcare Canada Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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K Number
K210719Device Name
Change Healthcare Anatomical AI
Manufacturer
Change Healthcare Canada Company
Date Cleared
2021-07-20
(132 days)
Product Code
QIH, CLA
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Change Healthcare Canada Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Change Healthcare Anatomical AI is intended to analyze pixel data from CT or MR images to create comprehensive anatomic descriptors for export to integrated healthcare systems.
This supplements traditional methods used for the selection, presentation or analysis of image based medical data. The application is intended to enable physicians, or other healthcare providers as well as integrated healthcare systems to rapidly identify images, series, and/ or studies of interest.
Change Healthcare Anatomical AI is not indicated for patients under the age of 18 years old.
Device Description
Change Healthcare Anatomical AI is a standalone image processing software application that analyzes CT and MR DICOM images to associate anatomic regions with images and exports the derived information for use in integrated healthcare systems. These anatomic descriptors can be applied by integrated applications to categorize anatomy from a patient's CT or MR image, series, or study.
The device communicates via Application Programmable Interfaces (APIs) which allow for receiving DICOM images and returning inference results. The algorithm produces a JSON file which contains results of the analysis for each image and study with the corresponding identified body regions.
Change Healthcare Anatomical AI works in parallel to and in conjunction with the standard of care workflow. The device does not alter the original medical image in any way. The anatomic descriptors are used as supplemental metadata for a patient's imaging study.
Change Healthcare Anatomical AI contains the following core components:
API endpoints
The device uses API endpoints which allow for receiving DICOM images and returning results.
Following receipt of an image, the device performs data validation to ensure appropriateness and compatibility for the algorithm. If the validation fails and the image cannot be processed, an error is returned with the corresponding code and description.
AI algorithm
After validation, the algorithm analyzes the CT or MR image pixel data and generates the anatomic descriptors.
Study results aggregator
The results of the analysis for each image in a study are aggregated and returned to the integrated system.
Data store
The results of the inference for each analyzed image are maintained in a persistent data store. The results are stored by the algorithm inference model and retrieved by the study results aggregation component.
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K Number
K181185Device Name
Change Healthcare Enterprise Viewer
Manufacturer
Change Healthcare Canada Company
Date Cleared
2018-08-29
(118 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Change Healthcare Canada Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Change Healthcare Enterprise Viewer is a software-based enterprise viewer intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content. Change Healthcare Enterprise Viewer is intended as well to facilitate collaboration and sharing of these materials within and outside the healthcare enterprise.
Change Healthcare Enterprise Viewer is intended to enable trained healthcare professionals to perform a diagnostic review on a workstation and non-diagnostic review on a mobile device, of a patient's medical images and to aid their clinical decision-making process.
Users access the application on a desktop computer or specific mobile devices through a standard web browser.
Change Healthcare Enterprise Viewer is not intended for diagnostic use on a mobile device. When used on a mobile device, Change Healthcare Enterprise Viewer is not intended to replace full workstations and should only be used when there is no access to a workstation.
Change Healthcare Enterprise Viewer is not intended for primary mammography diagnosis.
Device Description
Change Healthcare Enterprise Viewer is an enterprise medical image viewer software application used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D & 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
Change Healthcare Enterprise Viewer is intended to connect to an existing Picture Archiving and Communication System (PACS) or Vendor Neutral Archive (VNA) and is used to display medical images of multiple for clinical review, sharing and collaboration purposes.
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