Segmentron Viewer

Primary DI
00860010268087
Brand
Segmentron Viewer
Company
DGNCT LLC
Model
1.0
Device description
Segmentron Viewer is a software product intended for processing and manipulating maxillofacial radiographic images. Segmentron Viewer allows users to perform the following functions:Viewing patient images (provides tools for image processing and viewing functions);Reading and 3D visualization of CBCT imagesGenerating editable 3D STL files (for educational purposes only).The device is indicated for use by medical professionals (such as dentists and radiologists), in patients 14 years and older with permanent teeth.Segmentron Viewer is a web application. It can be used in a network environment.
Published
2026-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251072000Segmentron ViewerDGNCT, LLC2025-09-09QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010268087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010268087008600102680878600102680870860010268087

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose dental x-ray system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some application software routines or groups of routines (packages) must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+15196194212support@diagnocat.com

Regulatory Flags#

DUNS number
119404729
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010268063Diagnocat1.02026-01-29

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