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DGNCT LLC

Matched from indexed company URL: DGNCT, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30251104253025110425DGNCT LLC1N2026-01-01333 Southeast 2nd Avenue 20th Floor, room 563 Miami FL US 33131

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860010268063Diagnocat - Diagnocat software is a radiological, automated, concurrent read computer-assisted detectionsoftware intended to aid in the detection of periapical radiolucency on permanent teethcaptured on maxillofacial Cone Beam CT images, only in patients where a dentalprofessional determined such images to be necessary to evaluate possible dentalabnormalities and where the dental professional has the appropriate knowledge and trainingto interpret and assess maxillofacial Cone Beam CT images. The device provides additionalaid for the dental professional to use in their identification of periapical radiolucency. Thedevice is not intended as a replacement for a complete dental professional’s review or theirclinical judgment that considers other relevant information from the patient or other imagesor patient history. The system is to be used by professionally trained and licensed dentalprofessionals.Diagnocat is indicated for use by dental professionals for the second-read of CBCTradiographs of permanent teeth in patients 22 years of age or older.+15196194212support@diagnocat.com
00860010268087Segmentron Viewer - 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.+15196194212support@diagnocat.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3114831274582948K252934DiagnocatMYN2026-01-15
3114831699401278K251072Segmentron ViewerQIH2025-09-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MYN12026-01-15
QIH12025-09-09

PMN#

GUDID#

Diagnocat - Diagnocat software is a radiological, automated, concurrent read computer-assisted detectionsoftware intended to aid in the detection of periapical radiolucency on permanent teethcaptured on maxillofacial Cone Beam CT images, only in patients where a dentalprofessional determined such images to be necessary to evaluate possible dentalabnormalities and where the dental professional has the appropriate knowledge and trainingto interpret and assess maxillofacial Cone Beam CT images. The device provides additionalaid for the dental professional to use in their identification of periapical radiolucency. Thedevice is not intended as a replacement for a complete dental professional’s review or theirclinical judgment that considers other relevant information from the patient or other imagesor patient history. The system is to be used by professionally trained and licensed dentalprofessionals.Diagnocat is indicated for use by dental professionals for the second-read of CBCTradiographs of permanent teeth in patients 22 years of age or older.

DGNCT LLC

2026-01-29

Segmentron Viewer - 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.

DGNCT LLC

2026-01-29