Technology | Remote Viewing Systems | November 07, 2016

Remote image viewing application receives FDA 510(k) clearance

November 7, 2016 — Utah-based healthcare technology company Novarad has recently received U.S. Food and Drug Administration (FDA) 510(K) clearance of its MobileRad native iPad application, which is now available on the App Store.

The Novarad MobileRad application integrates with a facility’s NovaPACS (picture archiving and communication system) to display data on a third-party mobile device for diagnostic use, specifically the native app (MobileRad) on iPad. NovaPACS is approved for the viewing, archiving, analysis, annotation, registration, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, etc.

The app allows healthcare providers to view images and reports anytime, anywhere.

Clinical testing was conducted independently by a panel of board-certified radiologists in the United States. Each radiologist agreed that images on the native app were comparable to those on the predicate NovaPACS workstation across seven modalities, and of adequate quality for clinical and diagnostic use.

Each radiologist agreed they made the same diagnosis on their iPad as they would have made on the workstation.

Mobile devices are not intended to replace a full workstation and should be used only when there is no access to a workstation and with respect to proper lighting conditions. They are also not to be used for mammography.

For more information: www.novarad.net


Related Content

News | PACS

April 11, 2024 — Mach7 Technologies, a company specializing in innovative medical imaging and data management solutions ...

Time April 11, 2024
arrow
News | Radiation Dose Management

April 11, 2024 — Prelude Corporation (PreludeDx), a leader in precision diagnostics for early-stage breast cancer ...

Time April 11, 2024
arrow
News | Mammography

April 11, 2024 — Volpara Health Technologies Ltd., a global leader in software for the early detection and prevention of ...

Time April 11, 2024
arrow
News | Society of Breast Imaging (SBI)

April 11, 2024 — iCAD, Inc., a global leader in clinically proven AI-powered cancer detection solutions, announced today ...

Time April 11, 2024
arrow
News | Cybersecurity

April 10, 2024 — The American Medical Association (AMA) released informal survey findings (PDF) showing the ongoing ...

Time April 10, 2024
arrow
News | Radiology Business

April 4, 2024 — FUJIFILM Healthcare Americas Corporation, a leading provider of diagnostic and enterprise imaging ...

Time April 04, 2024
arrow
Feature | Radiology Business | By Melinda Taschetta-Millane

Here is a snapshot of the Top 10 most-read content from ITN's viewers during the month of March: 1. Philips Teams with ...

Time April 04, 2024
arrow
News | PACS

April 3, 2024 — aycan, a recognized leader in medical imaging, has introduced aycan mini PACS. Designed for smaller ...

Time April 03, 2024
arrow
News | Radiology Imaging

April 3, 2024 — GE HealthCare announced the U.S. FDA 510(k) Clearance of IONIC Health’s nCommand Lite technology. The ...

Time April 03, 2024
arrow
News | Radiology Business

April 2, 2024 — Less than three months after signing an agreement to acquire MIM Software Inc., GE HealthCare ...

Time April 02, 2024
arrow
Subscribe Now