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FDA-cleared K203555

AmCAD-UT

AmCad BioMed Corporation

Authorized purpose: Assist analysis of user-selected discrete thyroid nodules larger than 1 cm on ultrasound when a biopsy recommendation is required, after the physician's initial image review.

Modality
Ultrasound
Anatomy
Thyroid; discrete thyroid nodules
Decision
2021-09-08
FDA-cleared K170069

AmCAD-UV

AmCad BioMed Corporation

Authorized purpose: AmCAD-UV classifies ultrasonic color-intensity data and lets users view primary pulsatile, secondary pulsatile, and unidentified signals in flow-Doppler ultrasound images. It is a general-purpose medical-image-processing tool for vascular pulsatility analysis and must not be used alone for primary diagnostic interpretation.

Modality
Ultrasound
Anatomy
Vascular structures; pulsatile flow signals
Decision
2017-04-26