FDA-cleared K252148

Butterfly Gestational Age Tool

Butterfly Network, Inc.

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;...

Modality
Ultrasound
Anatomy
Obstetric/Fetal
Decision
2026-03-27
FDA-cleared K220068

Butterfly iQ/iQ+ Ultrasound System

Butterfly Network, Inc.

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...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2023-03-31