Radiology AI Directory

FDA-cleared profile

HealthOST

NanoxAI Ltd.

Authorized purpose: Qualitative and quantitative spine analysis from CT images to support clinician evaluation of musculoskeletal spinal disease, including vertebral labeling, vertebral height-loss measurement, and mean vertebral Hounsfield-unit measurement in patients aged 50 and over.

MSK and boneQuantification and segmentation
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: Qualitative and quantitative spine analysis from CT images to support clinician evaluation of musculoskeletal spinal disease, including vertebral labeling, vertebral height-loss measurement, and mean vertebral Hounsfield-unit measurement in patients aged 50 and over.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Qualitative and quantitative spine analysis from CT images to support clinician evaluation of musculoskeletal spinal disease, including vertebral labeling, vertebral height-loss measurement, and mean vertebral Hounsfield-unit measurement in patients aged 50 and over.

Evidence takeaway

Evidence from the reviewed source record: FDA stand-alone retrospective testing used 150 anonymized CT cases containing 1,425 vertebrae from two healthcare institutions with multiple US and OUS clinical sites; ground truth was determined by three US board-certified radiologists. Overall vertebral-naming agreement was 91.49% (95% CI [89.91%, 92.89%]); height-loss 95% limits of agreement were [-7.98, 7.36], with 91.86% of differences within the ground-truth readers' limits; agreement for classifying height loss above or below 20% was 91.28%; bone-attenuation 95% limits of agreement were [-20.83, 18.29], with 96.06% of differences within ground-truth readers' limits. These are agreement and limits-of-agreement endpoints, not sensitivity or specificity.

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
Qualitative and quantitative spine analysis from CT images to support clinician evaluation of musculoskeletal spinal disease, including vertebral labeling, vertebral height-loss measurement, and mean vertebral Hounsfield-unit measurement in patients aged 50 and over.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Clinicians, including radiologists and physicians in emergency medicine, specialty care, urgent care, and general practice.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Clinical-center radiology infrastructure and parallel clinical imaging workflow; the FDA packet does not specify a facility type beyond clinical use.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Post-acquisition DICOM CT validation and analysis in parallel with standard image storage and clinician availability, with automated vertebral labeling, segmentation, height and HU measurements, configurable flags, and clinician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
DICOM CT scans of patients aged 50 and over undergoing any clinical indication, with at least four vertebrae in the T1-L4 portion for height-loss analysis and the T11-L4 portion for bone attenuation; FBP-reconstructed images only. Sagittal scans are intended, with axial scans as backup when sagittal scans are unavailable.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
For each analyzed vertebra, a vertebral name, percentage height loss based on anterior/middle/posterior measurements, an indication when height loss exceeds a configurable threshold defaulting to >20%, mean trabecular-bone HU for T11-L4 with a configurable low-attenuation indication, and flags for significant height deviation from neighboring vertebrae.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Use is limited to patients aged 50 and over, FBP-reconstructed CT, and the required vertebral coverage. Height-loss and bone-attenuation display thresholds are configurable from predefined lists. Axial analysis is a backup when sagittal data are unavailable, and the device is not intended as a standalone diagnostic tool.
  • 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
K213944
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Spine, including T1-L4 vertebrae and T11-L4 trabecular bone regions
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-04-22
  • 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 packet describes DICOM-compliant clinical-center infrastructure, IMA integration for study results, and error codes for validation or analysis failure; it does not establish a specific PACS, RIS, EHR, interface version, or hosting model.
  • 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

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 HealthOST; 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 retrospective testing used 150 anonymized CT cases containing 1,425 vertebrae from two healthcare institutions with multiple US and OUS clinical sites; ground truth was determined by three US board-certified radiologists. Overall vertebral-naming agreement was 91.49% (95% CI [89.91%, 92.89%]); height-loss 95% limits of agreement were [-7.98, 7.36], with 91.86% of differences within the ground-truth readers' limits; agreement for classifying height loss above or below 20% was 91.28%; bone-attenuation 95% limits of agreement were [-20.83, 18.29], with 96.06% of differences within ground-truth readers' limits. These are agreement and limits-of-agreement endpoints, not sensitivity or specificity.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

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

HealthOST regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K213944
  • Samplen=150
  • IndependenceIndependence not established

K213944

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 K213944 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 K213944. 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
24Fields 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 K213944: HealthOST

    U.S. Food and Drug Administration - Published 2022-04-22 - 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. HealthOST model card (K213944)

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

    Scope: intendedUsers, careSetting, output, limitations, 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 K213944

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

    Scope: postmarketSafety

Research history

  1. K213944 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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