Meet MDPC-8127, our ultra-high definition medical grade display designed exclusively for digital pathology. With regulatory clearances as an IVD device (Europe and FDA) for use in digital pathology including primary diagnosis, it’s the first display that you can confidently integrate into your digital pathology workflow with multiple whole slide imaging systems.* Work with superior imaging technology and analyze your histological samples confidently, with unprecedented visual richness. *In the USA the MDPC-8127 can be used with WSI scanners and viewing software that have been validated for use with the display. The device may be used for primary diagnosis in the following validated FDA-cleared WSI systems and digital pathology viewing software:
Barco’s MDPC-8127 510(k) clearance:
✔ Philips Intellisite Pathology Solution with Philips Image Management System viewing software, cleared under K192259
✔ Philips Intellisite Pathology Solution with Paige.AI Inc. FullFocus DX viewing software, cleared under K201005
✔ Leica Aperio AT2 DX System with ImageScope DX viewing software, cleared under K190332
✔ Leica Aperio AT2 DX scanner with Sectra Digital Pathology Module, cleared under K193054
FDA- Cleared WSI systems and Digital Pathology Viewing Software with MDPC-8127:
✔ Hamamatsu NanoZoomer S360MD slide scanner system, cleared under K233027
✔ Leica Aperio GT 450 DX scanner with Aperio WebViewer DX, cleared under K232202
✔ Philips Intellisite Pathology Solution with JelloX MetaLite Dx Digital Pathology Software, cleared under K240303
✔ Philips IntelliSite Pathology Solution with Philips Image Management System and Galen™ Second Read™ AI, cleared under K241232
✔ Epredia E1000 Dx scanner with E1000 Dx IMS, cleared under K241717
✔ Hamamatsu NanoZoomer S360MD scanner with Lumea Viewer+, cleared under K242244
✔ Hamamatsu NanoZoomer S360MD scanner with PathPresenter Clinical Viewer, cleared under K250968
MDPC-8127 Validation protocol:
✔ Leica Aperio GT 450 DX scanner with Sectra Digital Pathology Module (3.3)
✔ Roche Ventana DP200 scanner with Roche uPath Enterprise Software
✔ Hamamatsu NanoZoomer S360MD Slide scanner with Proscia Concentriq® AP-Dx Digital Pathology software
The MDPC-8127 has been subjected to Barco’s ecoscoring protocol and has received an A+ rating. Some key factors that contributed to this rating are:
✔ High energy efficiency
✔ Possibility to switch to standby mode when device is not in use
✔ Use of halogen-free materials on all levels: cables, PCBs, plastics
✔ Number of screws and screw types is reduced significantly to improve ease of disassembly
✔ Unpainted large plastic parts