FDA Lets Proscia Add Scanners Without New 510(k)s

FDA cleared a new 510(k) for Proscia’s Concentriq AP-Dx digital pathology platform on 6 August, adding compatibility with a second whole-slide scanner and cloud deployment. The scanner addition is routine. What is not routine is the mechanism riding along with it: a predetermined change control plan, or PCCP, that lets Proscia add future scanners, image formats, and displays to the cleared platform without filing a new 510(k) for each one.

What changed, and what the PCCP changes going forward

Concentriq AP-Dx is Proscia’s software platform for primary diagnosis from digitized whole-slide images — the pathologist reads a scanned slide on screen rather than glass under a microscope. The platform first cleared in February 2024 for use with Hamamatsu’s NanoZoomer S360MD scanner. The 6 August clearance adds a second scanner, Leica’s Aperio GT 450 DX, and adds cloud deployment as an option for running the platform.

That much is a conventional hardware-compatibility expansion, the kind of 510(k) digital pathology vendors file routinely as they add scanner partners. The PCCP is the part that changes Proscia’s regulatory posture going forward. A predetermined change control plan is a scope of future modifications that a sponsor specifies and FDA reviews and authorizes in the original submission — so a later change that falls inside that pre-cleared scope does not trigger a new marketing submission on its own. Ian Cadieux, Proscia’s head of quality and regulatory, framed the appeal to customers rather than to FDA: “Laboratories choose a digital pathology platform with the expectation that it will sit at the center of their practice for years to come. The PCCP helps us to protect that investment, giving customers confidence that Concentriq AP-Dx will continue to be an interoperable foundation as their needs evolve.”

“The PCCP helps us to protect that investment, giving customers confidence that Concentriq AP-Dx will continue to be an interoperable foundation as their needs evolve.” Ian Cadieux, Head of Quality and Regulatory, Proscia, 6 August 2026

Why this is bigger than one scanner

FDA has mostly discussed PCCPs in the abstract until now — as a mechanism in guidance documents, aimed chiefly at software that updates its own algorithm over time. Proscia’s clearance is a concrete instance of the plan being used for something more mundane and, for a device vendor, more consequential day to day: hardware interoperability. A digital pathology platform’s commercial value depends heavily on which scanners, image formats, and monitors it works with, and each new one has historically meant a new submission and a new review clock. A PCCP that pre-clears the addition of “additional FDA-cleared scanners, image formats, and displays” converts that recurring regulatory cost into a one-time review, provided the changes stay inside the scope FDA already authorized.

For other software-driven device makers watching how FDA is reworking its device review clock more broadly, Proscia’s clearance is a data point on what a well-scoped PCCP can buy in practice: not a shortcut around FDA review, but a shift of that review earlier and into fewer, larger submissions. The FDA has not published the new clearance’s 510(k) number in its public database as of this writing; readers can track it directly in FDA’s 510(k) database once indexed.