Indications of Use

eRAD PACS is a software-only medical device used to receive medical images, scheduling information and clinical reports, organize and store them in an internal format, and make the information available across a network via web and customized user interfaces.

eRAD PACS includes software intended for use by qualified professionals for the presentation, review and comparison of diagnostic medical images.

eRAD PACS is for hospitals, imaging centers, reading practices, radiologists, technicians, physicians and other users who require and are granted access to patient image, exam and report information.

The eRAD PACS viewer displays images from DICOM compliant modalities and other devices including CT, computed and digital radiography, MRI, mammography, nuclear medicine, PET, secondary capture, ultrasound, x-ray angiography, x-ray fluoroscopy and visible light systems.

When displaying mammography images for clinical interpretation, only monitors having regulatory clearance for mammography interpretation should be used.

Contraindications

Irreversibly (lossy) compressed images and digitized film images should not be used for primary diagnosis of mammography studies.

The eRAD PACS web viewer should not be used for diagnostic review when used on a mobile device.

Clinical Claims, Benefits and Residual Risks

The clinical benefit of an eRAD PACS system are as follows:

• Presentation of digital medical images to healthcare professionals for diagnostic interpretations and improved patient management.
• Dynamic image presentation of full-fidelity diagnostic images, including size, resolution and contrast, compared to printed film.
• Centralized storage of, and remote access to, patient’s medical images and diagnostic reports.
• Elimination of the use of environmentally hazardous film processing chemicals.

eRAD PACS is for use by medical professionals to display the data from which the user renders a diagnostic opinion.

There are no clinical claims for this product.

The residual risks identified as a result of the risk evaluation are as follows:

• Cybersecurity attack
• Data loss and corruption due to hardware anomaly
• Data, intercommunication or compression incompatibility
• Software anomaly

Serviceable Life of Device

eRAD PACS shall be declared obsolete based on the following criteria:

• The required runtime platform is no longer commercially available.
• The required operating system and system-level components are no longer available or supportable, or are vulnerable to security attacks for which no protection is available.
• The manufacturer publicly announces the end of the device’s life cycle.