Radiology AI Directory

FDA-cleared profile

BlineSlide

Deep Breathe, Inc.

Authorized purpose: Lung ultrasound cine processing for B-line artifact presence/absence detection.

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

Product overview

Start with the essentials

Authorized purpose: Lung ultrasound cine processing for B-line artifact presence/absence detection.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Lung ultrasound cine processing for B-line artifact presence/absence detection.

Evidence takeaway

Evidence from the reviewed source record: FDA standalone performance assessment used 1,005 cines from geographically distinct development and test sources; ground truth was consensus of at least two experts, with 25 poor-quality clips excluded and a final set of 326 B-line-present and 679 B-line-absent examples. Sensitivity and specificity were co-primary endpoints with Cannot Evaluate scored as false predictions: sensitivity 0.91 (95% CI 0.88-0.94) and specificity 0.84 (0.81-0.86). The FDA summary states clinical testing was not required for this device type.

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
Lung ultrasound cine processing for B-line artifact presence/absence detection.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Physicians credentialed to use lung ultrasound clinically, including intensivists, emergency physicians, pulmonologists, general practitioners, or other clinicians interpreting the source cines.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Any setting where credentialed physicians perform lung ultrasound, including hospital, outpatient, remote, or austere environments.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Measurement/quantification support for physician-led lung ultrasound; results are not for sole patient-management decisions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
User-uploaded B-mode lung-ultrasound cines in MP4 format from anterior or anterolateral chest regions, acquired with non-linear-array transducers at at least 18 fps, 2.6-7.8 seconds duration, and no more than 2048 MB.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Presence or absence of B-line artifacts for each uploaded cine, displayed in a summary table; unsupported cines return Cannot Evaluate.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Incompatible with linear-array cines, less than 18 fps, more than 2048 MB, shorter than 2.6 seconds, or longer than 7.8 seconds. Cannot Evaluate outputs were scored as false predictions in FDA performance analysis; the device does not replace manual interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K252007
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Chest/Lung
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-10-06
  • 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
Cloud service using user-uploaded MP4 cines; the FDA packet expressly says it does not directly interface with ultrasound systems and treats MP4 as DICOM-equivalent for this use. PACS, RIS, EHR, HL7, and FHIR integration are not established by the packet.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-cloud
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for BlineSlide; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission ยท checked 2026-09-08
Source

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
FDA standalone performance assessment used 1,005 cines from geographically distinct development and test sources; ground truth was consensus of at least two experts, with 25 poor-quality clips excluded and a final set of 326 B-line-present and 679 B-line-absent examples. Sensitivity and specificity were co-primary endpoints with Cannot Evaluate scored as false predictions: sensitivity 0.91 (95% CI 0.88-0.94) and specificity 0.84 (0.81-0.86). The FDA summary states clinical testing was not required for this device type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
91% (95% CI: 88%, 94%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
84% (95% CI: 81%, 86%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

BlineSlide regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K252007
  • Samplen=1005
  • IndependenceIndependence not established

K252007

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K252007 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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 exact-identifier FDA recall query returned no native recall record for K252007. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

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.

Exact FDA record reviewedStatus
2026-09-20Last searched
25Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, 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. FDA K252007: BlineSlide

    U.S. Food and Drug Administration - Published 2025-10-06 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. BlineSlide model card (K252007)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, anatomy, evidenceStudies

  4. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K252007

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K252007 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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