Radiology AI Directory

FDA-cleared profile

Lumify Diagnostic Ultrasound System

Philips Ultrasound, LLC

Authorized purpose: Diagnostic ultrasound; assisted abdominal FAST acquisition and anatomical labeling

Cardiac imagingUltrasound 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: Diagnostic ultrasound; assisted abdominal FAST acquisition and anatomical labeling

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Diagnostic ultrasound; assisted abdominal FAST acquisition and anatomical labeling

Evidence takeaway

Evidence from the reviewed source record: FDA review includes a retrospective FAST labeling evaluation of 82 emergency-department patients and 229 loops, plus a separate 20-patient clinical bench evaluation. These are anatomical-labeling studies, not evidence of improved trauma 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
Diagnostic ultrasound; assisted abdominal FAST acquisition and anatomical labeling
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Intended users
Qualified healthcare professionals trained in ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Care setting and population
Healthcare environments; FAST Auto Assist is limited to adults
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Workflow role
Image acquisition support and anatomical labeling
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Required input
Live ultrasound from compatible Lumify transducers; FAST Auto Assist uses S4-1 or C5-2 abdominal imaging
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Output and human action
Ultrasound images and FAST organ/zone labels for right upper quadrant, left upper quadrant and suprapubic views
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Limitations
FAST Auto Assist is Android-only, adult-limited and available with S4-1/C5-2 transducers. Anatomical labels do not establish free-fluid diagnosis or replace clinician interpretation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

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
K252558
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Anatomy
Abdomen; Heart/Cardiovascular; Obstetric/Gynecologic; Musculoskeletal; Lung; Small parts
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

System indications span multiple organs, including fetal/obstetric, abdominal, pediatric, cephalic, urologic, gynecologic, cardiac, vascular, musculoskeletal and lung imaging. FAST Auto Assist is abdominal only.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-05-05
  • 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
The current Lumify app describes DICOM Store, Modality Performed Procedure Step and Storage Commitment support
  • Public source
  • Product family
  • Checked 2026-09-05

Current family documentation does not establish the supported phone, OS or interface configuration for a purchased K252558 system.

Deployment and data flow
Compatible mobile device application with USB-connected transducer; system supports Android and iOS, but FAST Auto Assist is Android-only
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

No scoped, dated security attestation for the proposed mobile-device and PACS configuration was reviewed.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Required local onboarding, competency assessment and FAST-specific training package were not established.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-05

Site-level label-error monitoring, update controls and support commitments remain to be confirmed.

DICOM workflow

Current Lumify app lists DICOM Store, MPPS and Storage Commitment

product family · checked 2026-09-05
Source

FAST platform restriction

Android with S4-1 or C5-2 transducer

exact submission · checked 2026-09-05
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 review includes a retrospective FAST labeling evaluation of 82 emergency-department patients and 229 loops, plus a separate 20-patient clinical bench evaluation. These are anatomical-labeling studies, not evidence of improved trauma outcomes.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05
Reported sensitivity
Retrospective zone-detection sensitivity ranged from 83.3% to 96.1% across zones; organ-label sensitivity ranged from 82.3% to 98.6% across organs
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

82 patients, 229 loops, clinician reference; category-specific ranges, not sensitivity for free fluid or a single product-wide endpoint.

Reported specificity
Retrospective zone-detection specificity ranged from 90.2% to 96.0%; organ-label specificity ranged from 89.0% to 96.0%
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-05

Category-specific anatomical-labeling results from 82 patients and 229 loops; not free-fluid specificity.

Overall FAST zone-detection accuracy

86 %

  • EndpointAgreement with clinician-reference FAST zone labels
  • Population82 emergency-department patients aged 18-89 with suspected free fluid; 229 ultrasound loops
  • Tested versionFAST Auto Assist evaluated in K252558; release number not stated
Source

K252558 FAST Auto Assist retrospective labeling evaluation

  • DesignRetrospective anatomical-labeling performance study; test sites separate from training sites
  • PopulationEmergency-department patients with suspected free fluid; 229 loops
  • Scopeexact submission
  • Tested versionK252558 FAST Auto Assist
  • Samplen=82
  • IndependenceIndependence not established

K252558

Separate limited 20-patient clinical bench evaluation is also described. Independent test data do not establish independent study sponsorship.

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 2026-09-05

A regional Philips subscription page did not establish current US pricing or inclusion of this FAST feature, hardware and support.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-09-05

No applicable current payer policy was reviewed. An older vendor ultrasound coding guide is not current CMS coverage evidence for FAST Auto Assist.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report 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
2026-09-05Last searched
14Fields reviewed
9Source classes checked
0Screened PubMed leads
1Screened trial leads
0Unreviewed FDA recall leads

NCT03486444 concerns next-generation ultrasound education and care; stored metadata screened, but exact FAST Auto Assist/version linkage was not established. Live registry page returned a JavaScript shell; no trial results promoted. The current discovery snapshot contains 0 PubMed and 1 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, vendor product page, literature index, clinical trial registry, recall database, 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. K252558 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. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  6. Lumify Diagnostic Ultrasound System: K252558 decision and 510(k) summary

    U.S. Food and Drug Administration - Accessed 2026-09-05

    Scope: identity, clinical, evidence, implementation

  7. Lumify app

    Philips - Accessed 2026-09-05

    Scope: integration, implementation

Research history

  1. K252558 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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