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510(k) Data Aggregation
K Number
K201296Device Name
i-Rapha Solution
Manufacturer
Date Cleared
2020-07-09
(55 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
IRM Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
i-Rapha Solution is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists and any user who requires and is granted access to patient image, demographic.
i-Rapha View, a component of i-Rapha Solution, displays and manages diagnostic quality DICOM images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display.
Device Description
The i-Rapha solution is a professional DICOM web browser application that conforms HTML5 standards to receive, store, and view DICOM images; utilizable under any web browser that supports HTML 5 protocols (e.g. Chrome Browser). This web browser application supports various types of annotation for medical images interpretation.
The i-Rapha solution is a software device that does not contact the patient, nor does it control any life sustaining devices. The software does not provide any diagnostic assistance to the physician.
The i-Rapha solution allows displaying of image studies that may not in the location as the modality. With its Web features, it is possible to review and manipulate the images of the studies located in a remote server. The i-Rapha View, a component of i-Rapha Solution, is an HTML5-based DICOM Viewer. The i-Rapha View can be used in any operating system because it can be executed by using a web browsers and especially Google Chrome that supports HTML5 regardless of the type of operating system.
Any diagnostic determination or treatment is solely determined by a physician and not the software. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.
The i-Rapha solution allows users to take full advantage of the radiographic images from various modalities in order to obtain invaluable mission critical diagnostic data and images.
The users can access their own diagnostic environment anywhere, anytime on PC.
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