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FDA-cleared K170250

SmartTarget

SmartTarget, Ltd.

Authorized purpose: SmartTarget is an accessory for image-guided interventional and diagnostic prostate procedures that enhances two-dimensional transrectal ultrasound, reconstructs three-dimensional ultrasound, and displays multiplanar views, annotations, and instrument location for procedures such as biopsy, ablation, and brachytherapy.

Modality
Ultrasound
Anatomy
Prostate
Decision
2017-06-07