Intelerad Receives FDA Clearance For Its PET/CT Image Fusion Module

Main Category: MRI / PET / Ultrasound
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 21 Aug 2009 - 1:00 PDT

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Intelerad Medical Systems, an industry-leading PACS solution vendor, is pleased to announce it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market and distribute its PET/CT Image Fusion product. This 510(k) clearance ensures that the PET/CT Image Fusion functionality can now be sold as a fully integrated module within Intelerad's signature IntelePACS solution. The efficiency gains for users from having a fully integrated solution compared to a stand alone workstation will be substantial.

"Intelerad is vigilant about maintaining high quality solutions that ensure interoperability with industry standards. For our PET/CT Image Fusion module, we followed the same stringent quality guidelines that are applied to all of our products. A thorough verification and validation cycle was conducted with validation received from actual users," explains Anibal Jodorcovsky, Intelerad's Executive Vice President of Quality Systems.

The PET/CT Image Fusion module is integrated within the InteleViewerTM viewing software, which gives radiologists the flexibility of viewing fused images from any IntelePACS® workstation and eliminates the need for expensive, dedicated PET/CT or SPEC/CT systems. With state-of-the-art fusion and advanced visualization technology, clinicians can view images using variable opacity, independent color maps, multiplanar Reformatting (MPR), and Maximum Intensity Projection (MIP). They also have access to specific PET/CT statistics such as Standard Uptake Values (SUVs) and volume measurements.

IntelePACS customers, such as West Michigan Cancer Center (WMCC), rely on Intelerad's expertise with workflow optimizing capabilities like PET/CT Image Fusion. "IntelePACS' Image Fusion module is an exciting new enhancement to WMCC's technology array. We have acquired a solution that will grow with us as more imaging modalities become available in the future. In addition, the freedom to provide this technology in many forms and varying locations makes it a great tool not only for our internal physicians but also for our patients' primary care physicians says Mike Fusko, CIO of WMCC. The PET/CT Image Fusion module provides WMCC with universal access to image fusion throughout their enterprise.

Source
Intelerad

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