Vendor
4 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Butterfly Network, Inc.
Authorized purpose: Butterfly Gestational Age Tool estimates gestational age for a singleton intrauterine pregnancy presumed to be 16 to 37 weeks within the labeled Butterfly ultrasound workflow; qualified professionals must review the output.
Butterfly Network, Inc.
Butterfly iQ3 is a general-purpose portable ultrasound system for adult and pediatric imaging, peripheral vessels, small organs, breast, thyroid, scrotum, cardiac, abdominal, lung, urologic, and procedural-guidance workflows.
Butterfly Network, Inc.
Authorized purpose: Butterfly iQ and iQ+ are handheld general-purpose ultrasound systems for adult and pediatric imaging; K220068 adds lung imaging, spectral pulsed-wave Doppler, and an Auto B-line Counter that identifies and counts B-lines for clinician review without diagnosing a specific pathology.
Butterfly Network, Inc.
Authorized purpose: Views, quantifies, and reports noninvasive bladder-volume measurements from Butterfly ultrasound systems to support physician diagnosis.