FDA-Device2020-04-08Class II
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
Butterfly Network, Inc.
Hazard
Distributed without an approved 510(k)
Sold states
US Nationwide distribution.
Affected count
15,121 host devices
Manufactured in
530 Old Whitfield St, N/A, Guilford, CT, United States
Products
Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1600-2020Don't want to check this manually?
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