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FDA-cleared K252235

PVAD IQ Software

Ultrasight, Ltd.

Authorized purpose: PVAD IQ supports qualified-physician clinical decision support by identifying the aortic annulus and PVAD inlet, calculating their mean distance, and identifying clips acceptable for this measurement.

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2025-12-18
FDA-cleared K251416

UltraSight Guidance

Ultrasight, Ltd.

Authorized purpose: UltraSight Guidance is an accessory to compatible general-purpose diagnostic ultrasound systems intended to assist medical professionals other than expert sonographers in acquiring cardiac ultrasound images. It is indicated for adult two-dimensional transthoracic echocardiography and acquisition of the specified parasternal, apical, and subcostal standard views.

Modality
Ultrasound
Anatomy
Adult heart; standard 2D transthoracic echocardiography views
Decision
2025-12-17