Segmentron Viewer

GUDID 00860010268087

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 images Generating 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.

DGNCT LLC

General-purpose dental x-ray system application software
Primary Device ID00860010268087
NIH Device Record Key3009994a-218c-49f1-b5f8-16e6b1c47f33
Commercial Distribution Discontinuation2027-01-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameSegmentron Viewer
Version Model Number1.0
Company DUNS119404729
Company NameDGNCT LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+15196194212
Emailsupport@diagnocat.com
Phone+15196194212
Emailsupport@diagnocat.com
Phone+15196194212
Emailsupport@diagnocat.com
Phone+15196194212
Emailsupport@diagnocat.com
Phone+15196194212
Emailsupport@diagnocat.com
Phone+15196194212
Emailsupport@diagnocat.com
Phone+15196194212
Emailsupport@diagnocat.com
Phone+15196194212
Emailsupport@diagnocat.com
Phone+15196194212
Emailsupport@diagnocat.com
Phone+15196194212
Emailsupport@diagnocat.com
Phone+15196194212
Emailsupport@diagnocat.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860010268087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIHAutomated Radiological Image Processing Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-06
Device Publish Date2026-01-29

Devices Manufactured by DGNCT LLC

00860010268063 - Diagnocat2026-02-06 Diagnocat software is a radiological, automated, concurrent read computer-assisted detection software intended to aid in the det
00860010268087 - Segmentron Viewer2026-02-06Segmentron 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 images Generating 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.
00860010268087 - Segmentron Viewer2026-02-06 Segmentron Viewer is a software product intended for processing and manipulating maxillofacial radiographic images. Segmentron

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