Device Directory
Browse 14 FDA-cleared medical devices
MetaLite DX Digital Pathology Software (K240303)
Class Class II K240303 QKQ
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) (K243222)
Class Class II K243222 QDS
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T (K233119)
Class Class II K233119 PZZ
FullFocus (K241273)
Class Class II K241273 QKQ
Galen Second Read (K241232)
Class Class II K241232 QPN
CaloPix (K250414)
Class Class II K250414 QKQ
RadiForce MX317W-PA (K242545)
Class Class II K242545 PZZ
PathPresenter Clinical Viewer (K250968)
Class Class II K250968 QKQ
AISight Dx (K243391)
Class Class II K243391 QKQ
ArteraAI Prostate (DEN240068)
Class Class II DEN240068 SFH
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