Radiology AI Directory

FDA-cleared profile

HealthICH

Zebra Medical Vision Ltd.

Authorized purpose: Case-level triage of adult non-contrast head CT examinations with features suggestive of intracranial hemorrhage (ICH); not a diagnostic or rule-out tool.

Stroke and ICH triageAcute triage and notification
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: Case-level triage of adult non-contrast head CT examinations with features suggestive of intracranial hemorrhage (ICH); not a diagnostic or rule-out tool.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Case-level triage of adult non-contrast head CT examinations with features suggestive of intracranial hemorrhage (ICH); not a diagnostic or rule-out tool.

Evidence takeaway

Evidence from the reviewed source record: Retrospective stand-alone validation used 427 anonymized head CT cases from the USA and Israel (199 ICH-positive and 228 negative), ages 18-102, truthed by two US board-certified neuroradiologists with a third senior neuroradiologist for disagreement. FDA reported sensitivity 94.47% (95% CI: 90.32%-97.21%), specificity 92.54% (95% CI: 88.33%-95.60%), overall agreement 93% (95% CI: 90.66-95.60), and mean per-case processing time 48.67 seconds (95% CI: 47.06-50.28).

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
Case-level triage of adult non-contrast head CT examinations with features suggestive of intracranial hemorrhage (ICH); not a diagnostic or rule-out tool.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Radiologists and other qualified medical staff who regularly read head CT scans
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Medical care environment
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Parallel case-level triage and notification support; standard-of-care review remains required and cases are not removed from the worklist.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
DICOM adult non-contrast head CT studies; input validation checks age, modality, and view compatibility.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
A case-level suspected-ICH notification is sent through the Zebra Imaging Analytics Platform to a PACS/workstation for worklist prioritization; no image, marking, or highlighted location is output.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Indicated only for adults and suspected ICH on non-contrast head CT. It does not address anomalies other than ICH, direct attention to an image location, make standalone clinical decisions, rule out hemorrhage, or preclude clinical assessment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K190424
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Head/brain
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2019-06-13
  • 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
After a head CT, a copy of the study is automatically retrieved and processed; HealthICH returns the notification to the Zebra Imaging Analytics Platform, which distributes it to the PACS/workstation through the worklist interface. The packet identifies DICOM images but does not establish a specific local PACS interface.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
On-premise
  • 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 2026-09-09

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 2026-09-09

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 2026-09-09

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

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Result destination

PACS and workstation are explicitly referenced as a result destination.

exact submission · checked 2026-09-01

Confirm supported products, versions, routing behavior, and display requirements during local evaluation.

Source

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

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

exact submission · checked 2026-09-09
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
Retrospective stand-alone validation used 427 anonymized head CT cases from the USA and Israel (199 ICH-positive and 228 negative), ages 18-102, truthed by two US board-certified neuroradiologists with a third senior neuroradiologist for disagreement. FDA reported sensitivity 94.47% (95% CI: 90.32%-97.21%), specificity 92.54% (95% CI: 88.33%-95.60%), overall agreement 93% (95% CI: 90.66-95.60), and mean per-case processing time 48.67 seconds (95% CI: 47.06-50.28).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Standalone per-case sensitivity for suspected ICH versus truthed ground truth: 94.47% (95% CI: 90.32%-97.21%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

FDA reports this endpoint for the 427-case retrospective head CT validation; it is not overall agreement or processing time.

Reported specificity
Standalone per-case specificity for suspected ICH versus truthed ground truth: 92.54% (95% CI: 88.33%-95.60%).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

FDA reports this endpoint separately from sensitivity, overall agreement, and the timing result.

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

HealthICH regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K190424
  • Samplen=427
  • IndependenceIndependence not established

K190424

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 2026-09-09

No public price or quote for the exact K190424 configuration was established in this review.

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

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 K190424. 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 2026-09-09

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
26Fields reviewed
9Source classes checked
1Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 1 PubMed and 0 ClinicalTrials.gov candidate record. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 1 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 K190424: HealthICH

    U.S. Food and Drug Administration - Published 2019-06-13 - Accessed 2026-09-09

    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. HealthICH model card (K190424)

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

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

  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 K190424

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

    Scope: postmarketSafety

Research history

  1. K190424 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

Alternatives

Related tools to compare

FDA-cleared K233247

Heuron ICH

Heuron Co., Ltd.

Triage and notification of suspected intracranial hemorrhage on non-contrast head CT in adults and transitional adolescents aged 18 years and older, to assist prioritization while...

Modality
CT/CTA
Anatomy
Head/brain
Decision
2024-05-15
Stroke and ICH triageAcute triage and notification
FDA-cleared K261317

BriefCase-Triage

Aidoc Medical, Ltd.

Adult head CTA or mCTA triage for suspected complete large-vessel and medium-vessel occlusion.

Modality
CT/CTA
Anatomy
Head/Brain
Decision
2026-05-14
Acute triage and notification
FDA-cleared K252421

JLK-NCCT

JLK, Inc.

Notification-only triage of adult non-contrast head CT for suspected intracranial hemorrhage and large-vessel occlusion, with parallel communication to trained clinicians during...

Modality
CT/CTA
Anatomy
Brain and intracranial vessels: intracranial hemorrhage and LVO involving ICA, MCA-M1, and MCA-M2
Decision
2026-03-24
Stroke and ICH triageAcute triage and notification