Radiology AI Directory

FDA-cleared profile

MediAI-OA

Crescom Co., Ltd.

Authorized purpose: Assist trained professionals in assessing radiographic knee osteoarthritis and its sclerosis, joint-space-narrowing, and osteophyte features on standing fixed-flexion knee radiographs.

X-ray/Radiography workflow
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: Assist trained professionals in assessing radiographic knee osteoarthritis and its sclerosis, joint-space-narrowing, and osteophyte features on standing fixed-flexion knee radiographs.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Assist trained professionals in assessing radiographic knee osteoarthritis and its sclerosis, joint-space-narrowing, and osteophyte features on standing fixed-flexion knee radiographs.

Evidence takeaway

Evidence from the reviewed source record: FDA K253172 packet describes an independent site-separated performance test with 1,173 independent test subjects and 11,383 knees. Key test endpoints were KL >=2 sensitivity 87.6% (95% CI 86.6%-88.5%) and specificity 86.5% (85.6%-87.3%); JSN >= OARSI grade 1 sensitivity 88.0% and specificity 86.4%; osteophyte >= OARSI grade 1 sensitivity 89.7% and specificity 82.3%; sclerosis sensitivity 88% and specificity 90%.

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
Assist trained professionals in assessing radiographic knee osteoarthritis and its sclerosis, joint-space-narrowing, and osteophyte features on standing fixed-flexion knee radiographs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Trained professionals including radiologists, orthopedists, physicians, and medical technicians.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Healthcare facilities and hospitals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Detection and assessment aid for knee OA features; human interpretation remains required.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM CR or DX knee radiographs; the comparison table also lists jpeg/jpg/png; standing, fixed-flexion knee radiographs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
KL grade 0/1, 2, 3, or 4; presence/absence of JSN, osteophytes, and sclerosis; screen, web-report, markup-image, and static textual-report outputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not in lieu of full patient evaluation and not to be solely relied on to make or confirm a diagnosis; trained professional interpretation is required.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K253172
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Knee joint
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2026-06-15
  • 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
DICOM-compliant image input and server-side processing are stated; the packet does not establish a specific PACS/RIS routing interface.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

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 2026-09-08

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 2026-09-08

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 2026-09-08

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

ACR exact-submission catalog context

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

exact submission · checked 2026-09-08
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 K253172 packet describes an independent site-separated performance test with 1,173 independent test subjects and 11,383 knees. Key test endpoints were KL >=2 sensitivity 87.6% (95% CI 86.6%-88.5%) and specificity 86.5% (85.6%-87.3%); JSN >= OARSI grade 1 sensitivity 88.0% and specificity 86.4%; osteophyte >= OARSI grade 1 sensitivity 89.7% and specificity 82.3%; sclerosis sensitivity 88% and specificity 90%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
Endpoint-specific sensitivity: KL >=2 87.6%; KL 0/1 86.5%; KL 2 71.7%; KL 3 75.0%; KL 4 90.5%; JSN >=1 88.0%; osteophyte >=1 89.7%; sclerosis 88.0%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

These knee-radiograph classification endpoints must not be collapsed into one device-level diagnostic sensitivity.

Reported specificity
Endpoint-specific specificity: KL >=2 86.5%; KL 0/1 87.6%; KL 2 86.2%; KL 3 97.2%; KL 4 99.5%; JSN >=1 86.4%; osteophyte >=1 82.3%; sclerosis 90.0%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

The previous baseline duplicated sensitivity values here; these are the FDA-reported endpoint-specific specificity values.

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

MediAI-OA regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K253172
  • Samplen=1173
  • IndependenceIndependence not established

K253172

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 2026-09-08

No public price or quote for the exact K253172 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K253172. 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 2026-09-08

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
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, acr ai central product, fda decision 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 K253172: MediAI-OA

    U.S. Food and Drug Administration - Published 2026-06-15 - Accessed 2026-09-08

    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. MediAI-OA model card (K253172)

    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 K253172

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K253172 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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