Butterfly iQ3 Ultrasound System
Butterfly Network, Inc.The Butterfly iQ3 Ultrasound System is a portable, hand-held ultrasound device used by trained healthcare professionals to capture diagnostic ultrasound images and measurements across multiple clinical areas such as cardiac, abdominal, lung, musculoskeletal, fetal/obstetric, and more. It offers various imaging modes and supports professional use in diverse healthcare environments, helping clinicians visualize anatomical structures and fluids for adult and pediatric patients.
Intended Use
The iQ3 Ultrasound System is indicated to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for multiple clinical applications including peripheral vessel, small organs, cardiac, abdominal, lung, procedural guidance, urology, fetal/obstetric, gynecological, musculoskeletal, and ophthalmic.
Technology
The device uses a capacitive micromachined ultrasonic transducer (CMUT) array instead of a traditional piezoelectric array, connects to a commercial mobile device via USB, and supports multiple imaging modes including B-mode, M-mode, Color Doppler, and spectral pulsed wave Doppler. It features new hardware elements such as a custom battery, new printed circuit boards, and a direct contact charging system, while maintaining software compatibility with existing host applications.
Performance
Verification and validation testing, including conformance to IEC 60601 and ISO 10993 standards along with software verification and validation, demonstrated the device meets predetermined performance specifications and is safe and effective. Clinical studies were not required for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/12/2023
3 months - 2
FDA Approval
1/4/2024
Other devices from Butterfly Network, Inc.
- Butterfly iQ/iQ+ Ultrasound System2023 • 510K
- Auto 3D Bladder Volume Tool2020 • 510K
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