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Butterfly Network, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories2
Latest Approval2026-03-27
TypeNumberDevice NameCodeDate
510(k) K252148 Butterfly Gestational Age Tool IYN 2026-03-27 View
510(k) K232808 Butterfly iQ3 Ultrasound System IYN 2024-01-04 View
510(k) K220068 Butterfly iQ/iQ+ Ultrasound System IYO 2023-03-31 View
510(k) K202406 Butterfly iQ Ultrasound System IYN 2020-09-16 View
510(k) K200980 Auto 3D Bladder Volume Tool IYO 2020-06-11 View
510(k) K163510 Poseidon Ultrasound System IYN 2017-09-06 View
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