Butterfly iQ/iQ+ Ultrasound System

by Butterfly Network  · Based in United States → — Democratizing medical imaging by making high-quality ultrasound affordable, easy-to-use, globally accessible, and intelligently connected.
Critical Care Emergency Medicine Radiology
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Device purchase + mandatory annual subscription.
Regulatory Status Disclosed

Overview

The Butterfly iQ/iQ+ Ultrasound System is a revolutionary handheld, single-probe, whole-body ultrasound device powered by proprietary Ultrasound-on-Chip™ technology. This innovative system replaces traditional piezoelectric crystals with a semiconductor chip, enabling it to emulate various probe types (linear, curved, phased array) for comprehensive imaging across the body. It connects to compatible iOS or Android mobile devices via the Butterfly iQ mobile application, providing real-time imaging and intuitive controls. The system integrates AI-powered tools such as Auto Bladder Volume Capture, Auto B-Line Counter, and NeedleViz™ technology for enhanced procedural guidance. Designed for portability and durability, the Butterfly iQ+ is water and dust resistant (IP67) and military-grade tested to withstand drops. It offers unlimited HIPAA and GDPR-compliant cloud storage for images and clips, facilitates communication among clinicians, and supports integration with standard hospital medical record systems (EHR, PACS, DICOM).

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Ultrasound-on-Chipu2122 Technology (single silicon chip replaces multiple probes)
  • Whole-body imaging with a single handheld probe
  • Compatible with iOS and Android mobile devices
  • 20+ anatomical presets and six imaging modes (B-Mode, M-Mode, Color Doppler, Power Doppler, Pulsed Wave Doppler)
  • AI-powered imaging tools (Auto Bladder Volume Capture, Auto B-Line Counter, NeedleVizu2122)
  • Unlimited HIPAA and GDPR-compliant cloud storage (Butterfly Cloud)
  • Military-grade durability (4-foot drop resistance, IP67 water/dust resistant)
  • Teleguidance functionality for remote assistance
  • In-app educational videos and resources
  • Integration with hospital medical record systems (EHR, PACS, DICOM Connector)

Use Cases

  • Point-of-care diagnostics in emergency medicine and critical care
  • Procedural guidance (e.g., vascular access, nerve blocks, joint injections)
  • Cardiac assessment (echocardiograms, blood flow)
  • Obstetric and fetal assessment
  • Lung assessment (e.g., B-line counter for respiratory conditions)
  • Musculoskeletal imaging and injury evaluation

What Physicians Need to Know

Evidence Base (guidelines, literature scope)
The Butterfly iQ/iQ+ Ultrasound System is supported by a growing body of literature, including observational studies demonstrating its effectiveness as a diagnostic ultrasound tool across various indications. It has received FDA 510(k) clearance for diagnostic ultrasound imaging and measurement in adult and pediatric patients for a wide range of clinical applications, including peripheral vessel, cardiac, abdominal, lung, urology, fetal/obstetric, gynecological, musculoskeletal, and ophthalmic assessments. The device's utility has been explored in diverse settings such as tele-guidance for remote military clinicians, emergency departments, and for lung imaging in patients with COVID-19.
Clinical Validation Studies
Clinical evaluations, including studies with emergency physicians, indicate that the Butterfly iQ+ performs well and meets the needs for a point-of-care ultrasound device, citing advantages like its single probe for multiple modalities, good image quality in most indications, and affordability. While some studies noted limitations such as a large probe footprint, lower cardiac imaging quality compared to traditional machines (though still adequate), and occasional overheating, these were often deemed surmountable. Comparative studies have shown comparable imaging capabilities to conventional ultrasound in specific applications, such as ophthalmic imaging. The Auto B-Line Counter feature has demonstrated a safety and effectiveness profile similar to predicate devices.
Alert Fatigue Management
While not a traditional clinical decision support system with drug interaction alerts, the Butterfly iQ/iQ+ incorporates features to streamline workflow and potentially reduce cognitive load. This includes a user-friendly interface with over 20 imaging presets for rapid selection. AI-powered tools like auto ejection fraction calculation and auto bladder volume calculation aim to automate measurements, simplifying the scanning process. The system also provides alerts for operational aspects like low battery and auto-cool initiation to ensure patient safety and device longevity.
Differential Diagnosis Support
The Butterfly iQ/iQ+ provides diagnostic ultrasound imaging across a broad spectrum of clinical applications, aiding physicians in visualizing anatomical structures and fluids to support differential diagnoses. AI-powered tools, such as auto ejection fraction calculation, auto bladder volume calculation, and the Auto B-Line Counter for lung scans, provide quantitative data and automated detection to assist in diagnosis. Furthermore, Butterfly Network has collaborated with Caption Health to integrate AI-guided solutions for cardiac ultrasound image capture and interpretation, enhancing early disease detection and management. However, it's important to note that 'Compass AIu2122 is not intended to provide information used to make decisions regarding diagnosis or therapeutic purposes.'
Guideline Update Frequency
The Butterfly iQ mobile application and probe firmware are regularly updated to provide the latest functionality and security features. Butterfly Network recommends regular app updates and states that the app requires an internet connection at least once every 30 days to ensure it has the latest updates and safety information. The company emphasizes continuous innovation through its software to add new features to the device.
Clinical Workflow Integration
Designed as a point-of-care ultrasound (POCUS) system, the Butterfly iQ/iQ+ integrates seamlessly with compatible smartphones or tablets, offering a mobile-first workflow. This allows clinicians to scan, document, upload, and review patient studies directly from the bedside. The system supports integration with Electronic Medical Records (EMR) and Picture Archiving and Communication Systems (PACS), facilitating data transfer and reducing system barriers. It also features built-in teleguidance functionality for remote collaboration and supports enterprise deployments with enhanced security controls through integrations like Jamf.
Decision Audit Trail
The Butterfly Enterprise solution provides tools for documentation and review of patient studies, which supports accountability and quality assurance processes. Patient data protection is enforced by requiring mobile device encryption with a password or passcode. Studies can be archived to Butterfly Cloud, and integration with EMR/PACS typically includes audit trail capabilities for actions performed within those systems.
Physician Tip

Leverage the Butterfly iQ/iQ+ for rapid, bedside diagnostic imaging across its wide range of presets to inform immediate clinical decisions, especially in acute care settings or resource-limited environments. Utilize the AI-powered tools for automated measurements (e.g., ejection fraction, bladder volume, B-lines) to enhance efficiency and objectivity. For complex cases or training, consider using the teleguidance feature for remote expert consultation. Regularly update the mobile application and probe firmware to access the latest features and security enhancements. Remember that while AI tools assist, clinical judgment remains paramount, as some AI features are not intended for diagnostic decision-making.

The Butterfly iQ/iQ+ system is designed for robust integration into existing healthcare IT infrastructure. It seamlessly connects with compatible iOS and Android mobile devices, and through Butterfly Enterprise, it offers direct data transfer to EMR and PACS systems. This facilitates a mobile workflow for scanning, documentation, and review. Enhanced security and management for enterprise deployments are supported through integrations with Mobile Device Management (MDM) solutions like Jamf, ensuring HIPAA compliance and secure access. The platform also supports teleguidance for remote collaboration and an AI Marketplace for compatible applications.

Details

Category Clinical Decision Support & Reference, Radiology & Imaging AI
Pricing Device purchase + mandatory annual subscription.
  • Device (iQ+): $2,699; Device (iQ3): $3,899; Annual Subscription (core features): $420/year; Pro App Membership: $1,500 (details on duration vary, potentially multi-year or lifetime for specific features/warranty)
DeploymentMobile device (iOS/Android) connected to a handheld probe, with cloud-based software.
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

The Butterfly iQ/iQ+ Ultrasound System (K220068) is a hand-held general-purpose diagnostic imaging system indicated for use by trained healthcare professionals for diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients across various clinical applications including Peripheral Vessel, Procedural Guidance, Small Organs, Cardiac, Abdominal, Lung, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal, and Ophthalmic.
Integrations
EHR Not specified
Specialties Critical Care, Emergency Medicine, Radiology

What the Web Says

The Butterfly iQ and iQ+ Ultrasound Systems are handheld, portable ultrasound devices that connect to a smartphone or tablet, offering a versatile tool for point-of-care diagnostics across various medical specialties. Physicians generally praise its portability, ease of use, and the convenience of having a single probe for multiple imaging modalities. While not a replacement for high-end cart-based machines, it's considered a valuable extension of the physical examination and a great screening tool.

Overall: Mixed

Strengths

  • Portability and compact design, fitting in a pocket.
  • Single probe for whole-body use, eliminating the need to switch transducers.
  • Good image quality for point-of-care ultrasound, sufficient for many diagnostic and procedural needs.
  • User-friendly and intuitive app/software with various presets and tools.
  • HIPAA/HITECH-compliant cloud storage with unlimited image storage and reporting features.
  • Cost-effective compared to traditional cart-based ultrasound machines.

Limitations

  • Image quality, while good for point-of-care, may be grainier or not as detailed as full-sized, dedicated ultrasound machines, especially for deep cardiac imaging.
  • Requires a subscription fee for full functionality, including cloud storage and advanced features.
  • Wired connection, which some users find less portable than wireless alternatives.
  • Non-removable battery with unclear longevity and replacement options.
  • Compatibility issues with certain Android devices and lack of consistent software updates for all platforms.
  • Concerns about customer support and the company's approach to product longevity and upgrades.

Based on reviews from: Reddit, Zebra Medical, Emergency Physicians Monthly, YouTube (Portable #ultrasound: Butterfly IQ+ - Advantages and disadvantages), MDEdge, TrialX, App Store (Butterfly iQ u2014 Ultrasound), Critical Care Northampton, ResearchGate (Advantages and disadvantages of the butterfly iQ)

Last updated: 2026-07-17

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Press & Coverage

FDA
510(k) Premarket Notification - Butterfly iQ/iQ+ Ultrasound System (K220068)
This regulatory document from the FDA details the 510(k) clearance for the Butterfly iQ/iQ+ Ultrasound System, outlining its indications for use, modes of operation, and substantial equivalence to predicate devices. It specifies the system's use for diagnostic ultrasound imaging in various clinical applications for adult and pediatric patients.
2023-03
Butterfly Network, Inc.
Butterfly iQu2122/ iQ+u2122 Personal Ultrasound System User Manual
This user manual provides comprehensive information about the Butterfly iQ/iQ+ Ultrasound System, including safety information, system overview, and setup instructions. It also details the clinical applications for which the device is indicated.
2023-07
Innolitics
Butterfly iQ/iQ+ Ultrasound System (K220068) u2014 FDA 510(k)
This entry provides an overview of the FDA 510(k) clearance for the Butterfly iQ/iQ+ Ultrasound System, including its regulatory classification and identification. It also mentions that the FDA may publish further announcements regarding the device.
2023-03
X-ray Interpreter
Butterfly Network | Radiology AI Companies - X-ray Interpreter
This article from X-ray Interpreter lists the Butterfly iQ/iQ+ Ultrasound System as a portable, handheld ultrasound device that received FDA clearance on March 31, 2023.
2023-03
HaRi
HaRi u00b7 Butterfly iQ/iQ+ Ultrasound System
HaRi provides regulatory registrations, clearances, and safety data for the Butterfly iQ/iQ+ Ultrasound System across various regulatory bodies including FDA, MHRA, Health Canada, TGA, and EUDAMED.
unknown
FDA
510(k) Premarket Notification - Butterfly iQ3 Ultrasound System (K232888)
This FDA document details the 510(k) clearance for the Butterfly iQ3 Ultrasound System, which is substantially equivalent to the predicate device K220068 (Butterfly iQ/iQ+). It highlights technological characteristics and features, including new hardware components and compatibility with the existing Butterfly iQ App.
2024-01
Innolitics
How much will an FDA clearance cost?
This article discusses the costs associated with FDA clearances for AI/ML medical devices, referencing the Butterfly iQ/iQ+ Ultrasound System's clearance on March 31, 2023, and its associated market impact.
2026-05
Innolitics
Butterfly Gestational Age Tool | FDA Radiology AI Device
This entry from Innolitics mentions the Butterfly iQ/iQ+ Ultrasound System as a previously cleared device in 2023, in the context of the Butterfly Gestational Age Tool's FDA clearance in 2026.
2026-03

Videos

Product demos, reviews, and walkthroughs for Butterfly iQ/iQ+ Ultrasound System.

View all on YouTube

Frequently Asked Questions

The AI in Butterfly iQ/iQ+ primarily optimizes image acquisition, guides users to obtain quality images, and offers automated measurements. Specific AI features include Auto Bladder Volume Capture, Auto B-Line Counter for lung assessments, and a fully automated Gestational Age (GA) Tool, which streamlines workflows and aims to reduce the learning curve for point-of-care ultrasound (POCUS) users.
The Butterfly iQ/iQ+ system, including its AI components like the Auto B-line Counter and Gestational Age Tool, has received FDA 510(k) clearance for human use. For data privacy, Butterfly Cloud is HIPAA-compliant, utilizing robust encryption (AES 256-bit for data at rest, TLS 1.2 for data in transit) and is SOC 2 certified, ensuring secure storage and transmission of patient information.
Butterfly iQ/iQ+ is distinguished by its single-probe, whole-body Ultrasound-on-Chipu2122 technology with integrated AI, offering a versatile and portable solution. While other handheld and cart-based systems also incorporate AI for image optimization and quantification, comparative studies indicate varying strengths in image quality and ease of use across devices, with no single system universally superior.
The Butterfly iQ/iQ+ system typically involves an upfront cost for the probe, followed by an annual subscription fee. This membership, which can range from Core to Advanced Technology tiers, covers access to advanced AI features, unlimited cloud storage, educational content, and software updates.
Like all AI, Butterfly iQ/iQ+'s algorithms have inherent limitations and potential biases based on their training data, and are intended as assistive tools, not replacements for clinical judgment. Physicians must maintain oversight, as the AI does not mark images for specific pathologies and its reliability for critical diagnoses requires expert interpretation.

Compare Butterfly iQ/iQ+ Ultrasound System

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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