Indications for Use

Last modified: May 15, 2024 (highlight most recent changes)

510(k) Number: K231360

Medical Device Name: InteleShare

The software is intended for use as a primary diagnostic and analysis tool for diagnostic images for hospitals, imaging centers, radiologists, reading practices and any user who requires and is granted access to Patient image, demographic and report information.

The ProViewer, a component of the software, displays, modifies and manages diagnostic quality DICOM images including 3D visualization and reordering functionality.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretations. Mammographic images may only be viewed using cleared monitors intended for mammography Display.

Not intended for diagnostic use on mobile devices.