Confidential 3
Release Notes Template (#935-01008, Revision 4.0) May 25, 2021
1 Introduction
1.1 Purpose
This document provides the release notes for release of NilRead v5.0 (v 5.0.4.109441)
Note this release is for English only installs. For other languages, please contact Hyland.
1.2 NilRead Intended Use Statement
In the U.S.:
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 and breast tomosynthesis. NilRead also allows users to collaborate by sharing
application sessions.
Lossy compressed mammographic images are not intended for diagnostic review. Mammographic
images should only be viewed with a monitor approved by FDA for viewing mammographic images. For
primary diagnosis, post process DICOM “for presentation” images must be used.
On mobile platforms, this device is not intended for diagnostic use.
In Canada:
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. NilRead also
allows users to collaborate by sharing application sessions. NilRead is for use with MRI, CT, Ultrasound,
Digital Fluoroscopy, Digital Angiography, X-ray, Mammography, DBT, ECG, Dicom RT and Nuclear
Medicine Images.
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 used 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.
In all other regions:
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 used 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.