Ultrasound

Butterfly iQ+ with AI

Butterfly Network

FDACE

Clinical Pulse

Verified clinician sentiment

Verified clinician reviews launching · Apply to contribute →

Reviews are signed by clinicians verified against their regulator's public register.

Inside the Auris+ Listing

Six more sections complete this device’s Auris+ Listing.

  • Inside the algorithm

    Pro

    Pro unlocks the five-stage editorial walkthrough of how this device's AI reaches a verdict — model architecture, training data, inference latency, and where the clinician stays in the loop.

  • Decision Ledger

    Pro

    Pro unlocks a private, cross-vendor log of every case you read on this device — what the AI called, what you concluded, and a one-line reason if you overrode it. Ready for the EU AI Act's deployer logging obligations when they land in 2028.

  • Clinical Evidence Deep Dive

    Pro

    Pro unlocks the structured clinical-evidence summary — study count, target patient population, and a tabular accuracy-metrics view drawn from peer-reviewed sources.

  • Peer-Reviewed Publications

    Pro

    Pro unlocks the curated peer-reviewed publication list with PubMed cross-links — the citation backbone of every editorial verdict.

  • Post-Market & Regulatory Conditions

    Pro

    Pro unlocks the post-market surveillance summary, recall record, and the conditions of approval that bound real-world use.

  • AI Algorithm Version History

    Pro

    Pro unlocks the chronological record of algorithm version changes — what changed when, drawn from manufacturer changelogs and regulatory filings.

Upgrade to Pro →

Regulatory Approvals

FDA
Butterfly iQ/Butterfly iQ+ Ultrasound System

K220068

CE
EU CE MDR

Safety Record

Class 2 Device Recall

FDA Class 2 recall (initiated March 2020) of the predecessor Butterfly iQ covering the Auto Ejection Fraction and Auto Bladder Volume software tools, which had been deployed without prior 510(k) clearance and were disabled via software update (FDA recall IDs 180221 and 180229). Class 2 denotes remote probability of serious adverse consequences.