ProKnow DS

ProKnow DS is a cloud-based medical image management and processing software system designed for radiation oncology. It allows healthcare professionals to archive, review, analyze, and interact with patient imaging data (CT, MR), treatment plans, dose distributions, and dose volume histograms to support clinical decision-making and research in radiation therapy settings.

The subject device adds two new features to the predicate: (1) manual 3D image registration enabling users to create, edit, and download spatial registration objects between image sets in different coordinate frames, and (2) Opportunity DVH algorithm that visualizes theoretical limits of structure sparing alongside achieved dose. Core functionality—data archiving, DICOM visualization, anatomy contouring, metric extraction, and cohort analysis—remains unchanged.

IEC 62366-1 (usability engineering), ANSI AAMI IEC 62304 (software life cycle), IEC 62083 (radiotherapy treatment planning safety), IEC 61217 (radiotherapy equipment coordinates), NEMA PS 3.1-3.20 (DICOM), IEC 82304-1 (health software safety), IEC 81001-5-1 (health software security), ISO 14971 (risk management), ISO 15223-1 and ISO 20417 (labeling and symbols).

ProKnow DS is substantially equivalent to predicate K182855 because the fundamental technological characteristics and intended use remain unchanged; new features (3D registration and Opportunity DVH) are complementary enhancements that do not alter core safety or efficacy. Verification and validation testing, regression testing of unchanged functions, and conformance to recognized consensus standards demonstrate the device meets established safety and performance criteria identical to its predicate.