AI devices with FDA product code NVI — Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

Product code NVI (“Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Clinical Toxcicology panel (1). The most recent decision was BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM on October 27, 2005.