Radiology AI Directory

FDA-cleared profile

CEPHX- Cephalometric Analysis Software

Orca Dental AI LTD

Authorized purpose: Cephalometric image analysis, simulation, visual treatment objective support, and consultation for dental and orthodontic professionals treating patients aged 14 years and older.

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: Cephalometric image analysis, simulation, visual treatment objective support, and consultation for dental and orthodontic professionals treating patients aged 14 years and older.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Cephalometric image analysis, simulation, visual treatment objective support, and consultation for dental and orthodontic professionals treating patients aged 14 years and older.

Evidence takeaway

Evidence from the reviewed source record: Verification of AI computer-generated landmarks in cephalometric tracing versus manual landmarks by orthodontic specialists evaluated 21 clinically significant landmarks; 99% of landmarks were identified, and the acceptance criteria of at least 85% of cases meeting the pass criteria were satisfied.

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
Cephalometric image analysis, simulation, visual treatment objective support, and consultation for dental and orthodontic professionals treating patients aged 14 years and older.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
Qualified dentists.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact intended-user section states that the software is to be used by qualified dentists.

Care setting and population
Dental and orthodontic imaging and treatment-planning workflows.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Cephalometric image analysis, simulation, visual treatment-objective support, and consultation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
A 2D cephalometric image.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact device description states that the user uploads a 2D cephalometric image; related dental-imaging and eligibility additions are not retained.

Output and human action
Cephalometric landmarks, measurements, analyses, simulations, and visual treatment-objective information for professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Limitations
Use is limited to the labeled age and dental or orthodontic workflow; the qualified professional remains responsible for diagnosis and treatment decisions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

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
K231396
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
X-ray/Radiography
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Anatomy
Head/Neck
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-01-31
  • 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 exact FDA summary establishes radiological image-processing software; current image-transfer, practice-management, and hosting interfaces require vendor confirmation.
  • 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.

Current product-family workflow context

CephX describes its current dental-imaging family as automated cephalometric analysis and treatment-planning support.

product family · checked 2026-09-08

Confirm exact-release availability, interfaces, hosting, security, support, and commercial terms during procurement.

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
Verification of AI computer-generated landmarks in cephalometric tracing versus manual landmarks by orthodontic specialists evaluated 21 clinically significant landmarks; 99% of landmarks were identified, and the acceptance criteria of at least 85% of cases meeting the pass criteria were satisfied.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The replacement uses only the exact packet's landmark verification study and reported acceptance results.

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.

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 K231396 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 K231396. 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
19Fields reviewed
10Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 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, vendor product page, fda device recall, literature index, trial registry, fda decision summary packet, 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 K231396: CEPHX- Cephalometric Analysis Software

    U.S. Food and Drug Administration - Published 2024-01-31 - Accessed 2026-09-19

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation, output, limitations, purpose, input, intendedUsers, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  5. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  6. CephX dental-imaging family

    CephX - Accessed 2026-09-04

    Scope: productFamilyContext, workflowRole, implementationCapabilities

  7. openFDA exact recall query for K231396

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

    Scope: postmarketSafety

Research history

  1. K231396 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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