Device product
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.
Z-1600-2020
Product summary
- Event
- Event 85185
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,121 host devices
- Official record key
device-enforcement:Z-1600-2020
Official wording
Reason: Distributed without an approved 510(k)
Code information: Software versions 1.13.0, 1.14.0, and 1.15.0 UDI: (01)00866646000206
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Distributed without an approved 510(k)