Radiology AI Directory

FDA-cleared profile

HealthVCF

Zebra Medical Vision Ltd.

Authorized purpose: Passive, prioritization-only, parallel-workflow notification for clinicians in bone-health settings to prioritize chest and abdominal CT cases suggestive of at least one vertebral compression fracture; it does not provide diagnosis or replace full evaluation.

MSK and boneAcute 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: Passive, prioritization-only, parallel-workflow notification for clinicians in bone-health settings to prioritize chest and abdominal CT cases suggestive of at least one vertebral compression fracture; it does not provide diagnosis or replace full evaluation.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Passive, prioritization-only, parallel-workflow notification for clinicians in bone-health settings to prioritize chest and abdominal CT cases suggestive of at least one vertebral compression fracture; it does not provide diagnosis or replace full evaluation.

Evidence takeaway

Evidence from the reviewed source record: FDA stand-alone detection testing used 611 retrospective chest and abdominal CT cases from the USA and Israel, including 306 cases positive for moderate or severe vertebral compression fractures and 305 negative cases with mild or no fracture, truthed by three US board-certified radiologists. The reported AUC was 0.9504 (95% CI [0.9348, 0.9660)); at the reported operating point sensitivity was 90.20% (95% CI [86.35%; 93.05%]) and specificity was 86.89% (95% CI [82.63%; 90.22%]); mean analysis time was 61.36 seconds. These are triage-detection endpoints for the defined cohort.

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
Passive, prioritization-only, parallel-workflow notification for clinicians in bone-health settings to prioritize chest and abdominal CT cases suggestive of at least one vertebral compression fracture; it does not provide diagnosis or replace full evaluation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Clinicians in Bone Health and Fracture Liaison Service programs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Medical bone-health setting operating in parallel with the radiology standard-of-care workflow, using a worklist application on PACS.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Post-acquisition parallel triage: a copy of the CT study is retrieved and analyzed, a passive flag is sent to Zebra Worklist, and bone-health clinicians review the case; the radiology worklist is unaffected and cases are not removed.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Chest and abdominal CT scans, with retrieved studies checked for compatible age, modality, and view before algorithmic analysis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
A passive notification or flag in the Zebra Worklist application for cases suggestive of at least one vertebral compression fracture, with three sagittal preview images for information only; no diagnostic information, markings, or treatment recommendations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The device does not send a proactive alert, does not provide diagnostic information beyond triage and prioritization, does not remove cases from the radiology worklist, and must not replace full patient evaluation or be relied on to make or confirm diagnosis. Preview images are informational only.
  • 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
K192901
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Vertebral bodies and spine as seen on chest and abdominal CT; suspected vertebral compression fractures
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2020-05-12
  • 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 CT acquisition, a copy of the study is retrieved and results pass through the IMA Integration feature to the Zebra Worklist application on a workstation/PACS workflow; exact interface versions and local compatibility are not established.
  • 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.

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 HealthVCF; 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
FDA stand-alone detection testing used 611 retrospective chest and abdominal CT cases from the USA and Israel, including 306 cases positive for moderate or severe vertebral compression fractures and 305 negative cases with mild or no fracture, truthed by three US board-certified radiologists. The reported AUC was 0.9504 (95% CI [0.9348, 0.9660)); at the reported operating point sensitivity was 90.20% (95% CI [86.35%; 93.05%]) and specificity was 86.89% (95% CI [82.63%; 90.22%]); mean analysis time was 61.36 seconds. These are triage-detection endpoints for the defined cohort.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
90.20% (95% CI: [86.35%; 93.05%]) at the reported operating point
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The FDA packet supports this sensitivity for the 611-case chest/abdominal CT triage cohort; it is bounded to the reported operating point and intended use.

Reported specificity
86.89% (95% CI: [82.63%; 90.22%]) at the reported operating point
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

The FDA packet supports this specificity for the 611-case chest/abdominal CT triage cohort; it is distinct from the AUC and CI bounds.

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

HealthVCF regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K192901
  • Samplen=611
  • IndependenceIndependence not established

K192901

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 K192901 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 K192901. 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
25Fields reviewed
9Source classes checked
2Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 2 PubMed and 0 ClinicalTrials.gov candidate records. 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 2 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 K192901: HealthVCF

    U.S. Food and Drug Administration - Published 2020-05-12 - 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. HealthVCF model card (K192901)

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

    Scope: intendedUsers, 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 K192901

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

    Scope: postmarketSafety

Research history

  1. K192901 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 K253578

BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

Aidoc Medical, Ltd.

BriefCase-Triage CARE Multi-Triage CT analyzes contrast and non-contrast chest, abdomen, or chest/abdomen CT in adults or transitional adolescents aged 18 and older to flag...

Modality
CT/CTA
Anatomy
Chest and abdomen; pneumothorax, pericardial effusion, large aortic aneurysm, and shoulder fracture/dislocation
Decision
2026-02-26
MSK and boneAcute triage and notification
FDA-cleared K243548

BriefCase-Triage

Aidoc Medical, Ltd.

Workflow triage and notification of suspect cases with three or more acute rib-fracture (RibFx) pathologies in adults or transitional adolescents aged 18 and older.

Modality
CT/CTA
Anatomy
Ribs
Decision
2024-12-11
MSK and boneAcute triage and notification