FDA-cleared profile

AutoDensity

Eos Imaging

Software estimates L1-L4 spine bone-mineral density from EOSedge dual-energy AP radiographs for opportunistic orthopedic pre-surgical assessment.

MSK and bone

Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.

Clinical fit

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose: Software estimates L1-L4 spine bone-mineral density from EOSedge dual-energy AP radiographs for opportunistic orthopedic pre-surgical assessment.

Intended users: Qualified imaging professionals and physicians trained for the represented anatomy and workflow.

Care setting and population: Hospital or outpatient imaging analysis and reporting environments.

Workflow role: Medical-image processing, measurement, quantification, visualization, and reporting support.

Required input: Supported DICOM images and release-specific user inputs.

Output and human action: Measurements, segmentations, visualizations, calculations, and reports for professional review.

Limitations: AutoDensity is not a DXA replacement; patients with suspected low bone density require confirmation using the standard clinical pathway.

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: K251078

Modality: X-ray/Radiography

Anatomy: Spine

Clearance type: 510(k)

Decision date: 2025-11-14

FDA status: FDA-cleared

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration: DICOM import and output to PACS, reporting, or downstream systems; validate identifiers, series selection, measurements, units, geometry, routing, and round trips.

Deployment and data flow: Software on a workstation, server, or supported virtual environment with release-specific licenses.

Security and privacy: Vendor documentation pending

Training and support: Only qualified imaging professionals and physicians trained for the represented anatomy and workflow. should operate or interpret the product. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.

Monitoring and change control: Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track these product-specific limits: AutoDensity is not a DXA replacement; patients with suspected low bone density require confirmation using the standard clinical pathway.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K251078 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

DICOM import and output to PACS, reporting, or downstream systems; validate identifiers, series selection, measurements, units, geometry, routing, and round trips.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

Source Source

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. AutoDensity is not a DXA replacement; patients with suspected low bone density require confirmation using the standard clinical pathway.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track these product-specific limits: AutoDensity is not a DXA replacement; patients with suspected low bone density require confirmation using the standard clinical pathway.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

Source Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.

Evidence summary: K251078 reports a 30-subject precision study and 253-subject agreement study. Within-subject CV was 2.23%; mean bias versus reference was 0.045 g/cm2 with limits of agreement from -0.088 to 0.178 g/cm2.

Reported sensitivity: Not applicable

Reported specificity: Not applicable

Within-subject coefficient of variation

2.23 %

Repeat AutoDensity precision in AutoDensity.

Tested version: AutoDensity release cleared in K251078

Source

Mean BMD bias

0.045 g/cm2

Agreement with reference in AutoDensity.

Tested version: AutoDensity release cleared in K251078

Source

K251078 FDA performance package for AutoDensity

Manufacturer precision and agreement studies · Adults undergoing EOSedge spine radiography and reference bone-density assessment

exact submission · Tested version: AutoDensity release cleared in K251078 · n=253 · Sponsor or vendor study

K251078

Manufacturer evidence submitted for clearance or approval; local clinical, technical, and workflow acceptance remains necessary.

Source

Economics and lifecycle

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost: Not established in reviewed sources

Reimbursement and coding: No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the product within the applicable imaging, procedural, or surgical service line and verify payer, site-of-service, and coding assumptions independently.

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance or approval.

Source

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 2026-09-02 openFDA device-recall snapshot contained no record matched to K251078 by exact submission identifier. This does not exclude product-family or later safety information.

Buyer worksheet

Open questions to take to the vendor

Verify security and privacy controls: Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Verify pricing and total cost: No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

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

2026-09-04Last searched

24Fields reviewed

9Source classes checked

5Unreviewed PubMed leads

0Unreviewed trial leads

0Unreviewed FDA recall leads

Recovered from the prior exact-submission extraction and normalized under the current provenance rules. Exact FDA materials, available current product-family sources, reimbursement context, and exact-identifier postmarket results were reviewed. Pricing, contracted services, enabled options, final security architecture, and local interoperability remain organization-specific evidence. Automated exact-name discovery found 5 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, fda decision material, vendor product page, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall

Sources

Source ledger

Sources accessed through 2026-09-03.

K251078 FDA decision source U.S. Food and Drug Administration · 2026-08-31
Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
Medicare Coverage Database Centers for Medicare & Medicaid Services · 2026-09-01
openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
EOS product documentation EOS imaging · 2026-09-03

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