Radiology AI Directory

FDA-authorized profile

OsteoDetect

Imagen Technologies, Inc.

Computer-aided detection and localization of distal radius fractures on adult wrist PA/LAT radiographs as an adjunct to clinician review.

MSK and boneDetection and CADe
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct 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
Computer-aided detection and localization of distal radius fractures on adult wrist PA/LAT radiographs as an adjunct to clinician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Clinicians in primary care, emergency medicine, urgent care, and specialty care such as orthopedics, as well as radiologists who review radiographs
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Care setting and population
Primary care, emergency medicine, urgent care, specialty care including orthopedics, and radiology settings
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Concurrent assisted-read detection and localization in PACS; annotated and original images are read together, and the device is adjunctive rather than a replacement for clinician review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
PA and LAT wrist radiographs of adults aged 22 and older, represented as CR/DR DICOM objects with proper tags, acquired on Philips Medical Systems DigitalDiagnost, Carestream Health DRX-1, or GE Discovery XR656; input filtering uses image characteristics and DICOM tags.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
An annotated DICOM radiograph is returned to the same patient study as the original. A detected case receives a bounding box and the label Distal Radius Fracture: DETECTED; a negative case receives Distal Radius Fracture: NOT DETECTED, along with an analysis message and labeling instructions. The algorithm also generates a confidence score and conditional probability map for localization.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
Clinicians must read the annotation concurrently with the original and must not use it as the primary interpretation. OsteoDetect is not designed for fractures other than distal radius fractures, may not detect a fracture in both PA and LAT views, and requires proper DICOM tags. It supports only the three named imaging systems; motion, incompatible hardware or parameters, false positives, false negatives, missing/delayed results, and incorrect results are identified risks.
  • 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
DEN180005
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Adult wrist, specifically the distal radius
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
De Novo
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2018-05-24
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-authorized
  • 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
DICOM Network Input and Output connect the device with a DICOM Storage Server, and the facility PACS displays annotated and original images for concurrent reading. The packet specifies a dedicated physical machine with at least 2 CPU cores, 16 GB RAM, 100 GB free space, 100 Mbps Ethernet, and vSphere ESXi 6.0 Update 2; a specific PACS product interface is not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.

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 is 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: GE;Philips;Carestream

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 OsteoDetect; 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
Standalone testing used an independent set of 1,000 images (500 PA and 500 LAT), with ground truth from three US board-certified orthopedic hand surgeons by majority opinion. FDA reported AUC 0.965 (95% CI: 0.953-0.976), sensitivity 0.921 (95% CI: 0.886-0.946), specificity 0.902 (95% CI: 0.877-0.922), PPV 0.813 (95% CI: 0.769-0.850), NPV 0.961 (95% CI: 0.943-0.973), and mean localization centroid distance 33.52 pixels (SD 30.03). A separate 24-reader, 200-case MRMC study reported an aided-versus-unaided AUC difference of 0.049 (95% CI: 0.019-0.080; p=0.0056); aided sensitivity was 0.803 (95% CI: 0.785-0.819) and aided specificity was 0.914 (95% CI: 0.903-0.924).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Standalone image-level distal-radius-fracture sensitivity at the predetermined operating point: 0.921 (95% CI: 0.886-0.946).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

FDA reports this standalone endpoint separately from the AUC, localization distance, and reader-aided sensitivity.

Reported specificity
Standalone image-level distal-radius-fracture specificity at the predetermined operating point: 0.902 (95% CI: 0.877-0.922).
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

FDA reports this standalone endpoint separately from reader-aided specificity and localization accuracy.

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

OsteoDetect regulatory performance study summary

  • DesignStand-alone performance and reader study (ACR AI Central category)
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission DEN180005
  • Samplen=1000
  • IndependenceIndependence not established

DEN180005

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 DEN180005 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 DEN180005. 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
2026-09-09Last searched
24Fields reviewed
10Source classes checked
1Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 1 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, acr ai central product, fda de novo summary, 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 DEN180005: OsteoDetect

    U.S. Food and Drug Administration - Published 2018-05-24 - 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. OsteoDetect model card (DEN180005)

    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 DEN180005

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

    Scope: postmarketSafety

Research history

  1. DEN180005 FDA decision

    Regulatory record

    De Novo

  2. Source-review record updated

    Research record

    fda record reviewed

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