Pathology— FDA advisory panel PA

339 FDA 510(k) clearances across 73 product codes since 1976.

By Andrew Weston — Installation Systems Engineer

Pathology is a small panel by clearance count but a disproportionately interesting one right now. Historically it held laboratory infrastructure — tissue processors, stainers, cryostats, and immunohistochemistry reagent systems. The modern story is digital: whole-slide imaging scanners, digital pathology viewing platforms, and the first algorithmic analysis tools for tissue images all clear through this panel, and that family of software clearances is young enough that most of its predicate chains are only a few links deep.

For anyone tracking clinical AI beyond radiology, this is the panel to watch: pathology's digitization is roughly a decade behind radiology's PACS transition, which makes today's filings here look structurally like early imaging-informatics clearances did — platform clearances first, analysis algorithms following. The panel's small historical volume means individual clearances carry more signal than they would in a crowded panel.

Clearances per year

last 10 years

Top product codes in the Pathology panel

all codes

Recent clearances in the Pathology panel

all clearances

Data sourced from openFDA. This site is unofficial and independent of the FDA.