Optiscan Imaging (ASX:OIL) lodged a 510(k) submission with the US Food and Drug Administration (FDA) for its InForm medical imaging device designed for pathology workflows, according to a Thursday filing with the Australian bourse.

The submission moves the device beyond its internal development, testing, and validation phase into a formal regulatory assessment process, with clearance being a precursor to its commercial marketing within the US.

The company said the US represents a "substantial commercial opportunity" for InForm given that its pathology market is still largely analogue and is only now starting to shift toward digital workflows.

Optiscan Imaging shares rose 4% in recent Thursday trade.