FDA-authorized DEN190040

Caption Guidance

Bay Labs, Inc.

Real-time acquisition guidance and image-quality optimization for medical professionals obtaining standard adult 2D-TTE views; the device supports image acquisition, while...

Modality
Ultrasound
Anatomy
Heart, including the standard PLAX, PSAX-AV, PSAX-MV, PSAX-PM, AP4, AP5, AP2, AP3, SubC4, and SC-IVC views.
Decision
2020-02-07