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# Paige Digital Pathology Viewer Cleared
- URL: https://www.fdaweb.com/paige-digital-pathology-viewer-cleared/
- Published: 2020-07-21T12:00:00.000Z
- Updated: 2026-09-14T16:21:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147248

FDA has cleared a Paige 510(k) for the FullFocus, a digital pathology image viewer for the purpose of primary diagnosis. The clearance allows in vitro diagnostic (IVD) use of FullFocus with FDA-authorized Philips Ultra Fast Scanner and paves the way for IVD use of FullFocus with additional IVD whole slide imaging (WSI) scanners in the future, the company says.

“The foundation for the FullFocus viewer was initially created and validated at Memorial Sloan Kettering Cancer Center to allow researchers and pathologists to intuitively view and navigate digital images of surgical pathology slides acquired on all major commercial brands of WSI scanners,” Paige says. After 18 months of daily use for retrospective slide review by dozens of practicing pathologists, the viewer was “further enhanced by Paige to meet the performance requirements for IVD use, with accurate color reproducibility, optimized viewing speeds and adherence to a certified quality management system,” it says.