Device Dossier

Radiology picture archiving and communication system application software

Device Dossier for Radiology picture archiving and communication system application software (Radiology picture archiving and communication system…

Intended purpose

The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and other patient-related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data, including mammography. NilRead also allows users to collaborate by sharing application sessions. Mammographic images should only be viewed with a monitor approved by the FDA for viewing mammographic images, or monitors with similar specifications. On portable (mobile) platforms, this device is not intended to replace full workstations and should be used only when there is no access to a workstation. It is the user’s responsibility to ensure the software is installed on appropriate hardware and to verify display image quality is suitable for the clinical application. Mobile use is not intended for diagnostic review of Mammography and DBT. NilRead is intended for use by physicians trained in reviewing and interpreting medical images.

TGA Public Summary