FDA-Device2020-04-08Class II
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of anatomical structures.
Hazard
Distributed without an approved 510(k)
Sold states
US Nationwide distribution.
Affected count
11,183
Manufactured in
530 Old Whitfield St, N/A, Guilford, CT, United States
Products
Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of anatomical structures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1601-2020Don't want to check this manually?
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