Keeping Digital Pathology Open: The Regulatory Framework Behind Concentriq AP-Dx

Interoperability in digital pathology means a consistent, trusted experience as laboratories add scanners, displays, and connected systems. Concentriq AP-Dx’s new FDA 510(k) clearance adds the Leica Aperio GT 450 DX and authorizes a Predetermined Change Control Plan — turning openness from an architectural principle into a repeatable, regulated process.