510(k) K163510 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Poseidon Ultrasound System
| Applicant | Butterfly Network, Inc., Guildford CT, US |
| Decision | Substantially Equivalent, Sep 6, 2017 |
| Received | Dec 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163510
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 17, 2020 | Butterfly Network, Inc. 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
Pro Terminated |
IYN | None listed |
| Mar 17, 2020 | Butterfly Network, Inc. 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 Usa Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.