FDA grants Candelis 510(k) approval

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Candelis has received 510(k) marketing clearance from the FDA for its ImageGrid mammography web viewer and ImageGrid radiology web viewer, which are now part of the ImageGrid RIS/PACS appliance technology suite.

The ImageGrid mammography web viewer and radiology web viewer are diagnostic tools enabling access to medical imaging studies from anywhere or time, according to the Irvine, Calif.-based Candelis. Both viewing applications are designed to accommodate multiple concurrent users without the need to invest in additional servers.

The company also said that as a multi-modality visualization solution, the viewers allow radiologists to view relevant prior studies from one workstation.