Radiology AI Directory

FDA-cleared profile

Butterfly iQ/iQ+ Ultrasound System

Butterfly Network, Inc.

Butterfly iQ and iQ+ provide handheld general diagnostic ultrasound for adult and pediatric patients; this release adds lung imaging, spectral pulsed-wave Doppler, and automated B-line detection and counting.

Ultrasound workflowDetection and CADe
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Butterfly iQ and iQ+ provide handheld general diagnostic ultrasound for adult and pediatric patients; this release adds lung imaging, spectral pulsed-wave Doppler, and automated B-line detection and counting.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Intended users
Trained healthcare professionals providing diagnostic ultrasound.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Care setting and population
Clinical environments where healthcare is provided, including bedside, clinic, hospital, and other supported point-of-care settings.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Portable ultrasound acquisition and measurement with an optional reviewed B-line overlay and count during lung scanning.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Live ultrasound data from the Butterfly transducer connected to a compatible commercial mobile device.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Output and human action
Ultrasound images, measurements, Doppler information, stored studies, and B-line overlays and counts.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Limitations
The B-line overlay does not diagnose a specific pathology. Users must interpret it with the examination and other clinical data; current iQ+ platform, integration, and security claims may not apply to every K220068 configuration.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K220068
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-03-31
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Mobile application and transducer workflow with product-family PACS or EMR connectivity; validate supported mobile operating systems, DICOM routing, patient matching, offline behavior, archive completeness, and fleet management.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Handheld transducer plus compatible iOS or Android device and licensed mobile or cloud services; map the exact transducer, app, operating system, and subscription to the cleared release.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Security and privacy
Current iQ+ materials describe encrypted storage and TLS in transit for the product family. Confirm these controls, mobile-device management, identity, audit, retention, support access, vulnerability handling, and data residency for the exact contracted K220068 architecture.
  • Public source
  • Product family
  • Checked 2026-09-03

Confirm the controls against the exact contracted architecture and release.

Training and support
Only trained healthcare professionals providing diagnostic ultrasound. should operate or interpret the system. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: The B-line overlay does not diagnose a specific pathology. Users must interpret it with the examination and other clinical data; current iQ+ platform, integration, and security claims may not apply to every K220068 configuration.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K220068 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

Mobile application and transducer workflow with product-family PACS or EMR connectivity; validate supported mobile operating systems, DICOM routing, patient matching, offline behavior, archive completeness, and fleet management.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

SourceSource

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. The B-line overlay does not diagnose a specific pathology. Users must interpret it with the examination and other clinical data; current iQ+ platform, integration, and security claims may not apply to every K220068 configuration.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: The B-line overlay does not diagnose a specific pathology. Users must interpret it with the examination and other clinical data; current iQ+ platform, integration, and security claims may not apply to every K220068 configuration.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

SourceSource

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
K220068 reports analytical validation on 6,000 deidentified cines from 253 sites and clinical performance evaluation in 99 subjects. The Auto B-line Counter was noninferior to clinician ground truth and consistent across age, sex, and body-mass-index subgroups, but no public numerical ICC is reported in the summary.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.

Analytical validation cines

6000 cines

  • EndpointB-line count and segmentation validation
  • PopulationButterfly iQ/iQ+ Ultrasound System
  • Tested versionButterfly iQ/iQ+ with Auto B-line Counter cleared in K220068
Source

Collection sites

253 sites

  • EndpointAnalytical validation dataset
  • PopulationButterfly iQ/iQ+ Ultrasound System
  • Tested versionButterfly iQ/iQ+ with Auto B-line Counter cleared in K220068
Source

Clinical evaluation subjects

99 subjects

  • EndpointNoninferiority to clinician ground truth
  • PopulationButterfly iQ/iQ+ Ultrasound System
  • Tested versionButterfly iQ/iQ+ with Auto B-line Counter cleared in K220068
Source

K220068 FDA performance package for Butterfly iQ/iQ+ Ultrasound System

  • DesignManufacturer multisite analytical validation and pivotal clinical noninferiority evaluation against expert B-line annotations
  • PopulationAdults aged 20-90 with diverse demographic and clinical characteristics
  • Scopeexact submission
  • Tested versionButterfly iQ/iQ+ with Auto B-line Counter cleared in K220068
  • Samplen=99
  • Sites253
  • IndependenceSponsor or vendor study

K220068

Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the device within the applicable imaging or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance.

Source

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K220068 by exact submission identifier.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
24Fields reviewed
8Source classes checked
20Awaiting review PubMed leads
10Awaiting review trial leads
0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA materials, current product-family sources, selected clinical literature, reimbursement context, and exact-identifier recall candidates were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 20 PubMed and 10 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, vendor product page, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. K220068 FDA decision source

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, purpose, modality, anatomy

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. Butterfly iQ+ handheld ultrasound system

    Butterfly Network - Accessed 2026-09-03

    Scope: productFamily, workflowRole, integration, training, implementationCapabilities, currentCommercialContext

  8. Butterfly iQ+ specifications and security information

    Butterfly Network - Accessed 2026-09-03

    Scope: productFamily, integration, security, implementationCapabilities, currentCommercialContext

Research history

  1. K220068 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

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