Device Directory
Browse 730 FDA-cleared medical devices
SKR 3000 (K250665)
Class Class II K250665 MQB
RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT (K250440)
Class Class II K250440 MUJ
Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) (K243880)
Class Class II K243880 IYO
uOmniscan (K243666)
Class Class II K243666 LLZ
EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (K250886)
Class Class II K250886 IYN
6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) (K243253)
Class Class II K243253 IYN
CardIQ Suite (K243672)
Class Class II K243672 JAK
CT Scanner TSX-501R/1 V11.1 (K243398)
Class Class II K243398 JAK
OPXION Optical Skin Viewer (OPXSV1-01F) (K242924)
Class Class II K242924 NQQ
Cranial 4Pi Immobilization (K243142)
Class Class II K243142 IYE
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