Authorized purpose: Segmentron Viewer is an AI web application for processing and manipulating maxillofacial radiographic images, viewing and segmenting three-dimensional CBCT data, and creating editable STL outputs for educational use.
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: Segmentron Viewer is an AI web application for processing and manipulating maxillofacial radiographic images, viewing and segmenting three-dimensional CBCT data, and creating editable STL outputs for educational use.
Overview status: Source-reviewed overview
What does this software do?Authorized purpose: Segmentron Viewer is an AI web application for processing and manipulating maxillofacial radiographic images, viewing and segmenting three-dimensional CBCT data, and creating editable STL outputs for educational use.
Which images or clinical context are in scope?Modality: CBCT Anatomy or clinical context: Maxillofacial anatomy and permanent dentition Input: Dental radiographs, CBCT, digital impressions, photographs, or other oral and maxillofacial inputs identified in the exact FDA labeling.
Who uses it?Intended users: Dental and maxillofacial professionals.
What does the software produce?Output: Dental or maxillofacial images, segmentations, measurements, visualizations, or planning outputs described in the exact FDA labeling.
What is its most important limitation?Key limitation: The labeling limits the population to patients age 14 or older with permanent teeth; editable STL output is educational and does not replace clinical judgment.
Clinical takeaway
Clinical role: Segmentron Viewer is an AI web application for processing and manipulating maxillofacial radiographic images, viewing and segmenting three-dimensional CBCT data, and creating editable STL outputs for educational use.
Evidence takeaway
Evidence from the reviewed source record: The exact FDA decision material reports standalone CBCT segmentation and labeling validation against reference standards. The reported Dice coefficients and labeling accuracy are endpoint- and subset-specific, not product-wide clinical outcome claims.
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
Segmentron Viewer is an AI web application for processing and manipulating maxillofacial radiographic images, viewing and segmenting three-dimensional CBCT data, and creating editable STL outputs for educational use.
Segmentron Viewer is an AI web application for processing and manipulating maxillofacial radiographic images, viewing and segmenting three-dimensional CBCT data, and creating editable STL outputs for educational use.
The labeling limits the population to patients age 14 or older with permanent teeth; editable STL output is educational and does not replace clinical judgment.
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Security controls, hosting boundaries, audit behavior, identity management, and incident commitments for the exact configuration are not established in the public FDA decision material.
Training and support
Use by the qualified healthcare professionals identified for the exact labeled workflow; site-specific competency and training requirements remain to be established locally.
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. The labeling limits the population to patients age 14 or older with permanent teeth; editable STL output is educational and does not replace clinical judgment.
exact submission · checked 2026-09-04
Define stop-use, escalation, rollback, and revalidation triggers before production use.
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 2026-09-04
No exact-product price was found in the evidence set; productivity or value claims require local evidence.
Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes; exact monitoring thresholds and vendor commitments are unknown.
exact submission · checked 2026-09-04
Establish ownership for data quality, overrides, drift, incidents, recalls, and change control.
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
The exact FDA decision material reports standalone CBCT segmentation and labeling validation against reference standards. The reported Dice coefficients and labeling accuracy are endpoint- and subset-specific, not product-wide clinical outcome claims.
K251072 FDA evidence package for Segmentron Viewer
DesignManufacturer-submitted retrospective standalone CBCT validation against expert reference standards; not independent clinical validation.
PopulationCBCT images in the exact Segmentron Viewer validation package.
Scopeexact submission
Tested versionExact FDA submission release; version not separately stated in the public decision material
Samplen=126
IndependenceSponsor or vendor study
K251072
Evidence submitted for the exact FDA decision is not independent clinical validation. Local technical, clinical, privacy, security, and workflow acceptance remains necessary.
These are common procurement questions; unknown values remain visible until a source supports them.
Pricing and total cost
Not established in reviewed sources
Reviewed sources checked
Exact FDA submission
Checked 2026-09-04
No public list price for the exact cleared configuration was found in the evidence set. Obtain a written quote covering license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, downtime, and exit costs.
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, dental, or surgical service line and verify payer, site-of-service, and coding assumptions independently.
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 K251072 by native exact submission identifier. This does not exclude product-family, later, or adverse-event information.
Public source
Exact FDA submission
Checked 2026-09-04
Exact-identifier review does not prove absence of all product-family safety signals.
Verify security and privacy controls: Security controls, hosting boundaries, audit behavior, identity management, and incident commitments for the exact configuration are not established in the public FDA decision material.
Verify pricing and total cost: No public list price for the exact cleared configuration was found in the evidence set. Obtain a written quote covering license or hardware basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, downtime, and exit costs.
Verify local validation and lifecycle monitoring: Post-deployment monitoring, drift thresholds, alerting, and revalidation commitments for the exact configuration require vendor and site confirmation.
This audit distinguishes completed source review from fields that have not yet been researched.
Human reviewedStatus
2026-09-20Last searched
27Fields reviewed
12Source 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, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, 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 history6 sources - 3 history items
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