Diagnocat

GUDID 00860010268063

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

DGNCT LLC

General-purpose dental x-ray system application software

• Primary Device ID: 00860010268063
• NIH Device Record Key: b80d63af-e131-4eb7-9560-47416cda1854
• Commercial Distribution Discontinuation: 2027-01-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diagnocat
• Version Model Number: 1.0
• Company DUNS: 119404729
• Company Name: DGNCT LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +15196194212
• Email: support@diagnocat.com
• Phone: +15196194212
• Email: support@diagnocat.com
• Phone: +15196194212
• Email: support@diagnocat.com
• Phone: +15196194212
• Email: support@diagnocat.com
• Phone: +15196194212
• Email: support@diagnocat.com
• Phone: +15196194212
• Email: support@diagnocat.com
• Phone: +15196194212
• Email: support@diagnocat.com
• Phone: +15196194212
• Email: support@diagnocat.com
• Phone: +15196194212
• Email: support@diagnocat.com
• Phone: +15196194212
• Email: support@diagnocat.com
• Phone: +15196194212
• Email: support@diagnocat.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010268063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252934

FDA Product Code

• MYN: Analyzer, Medical Image

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-06
• Device Publish Date: 2026-01-29

Devices Manufactured by DGNCT LLC

• 00860010268063 - Diagnocat: 2026-02-06Diagnocat software is a radiological, automated, concurrent read computer-assisted detection software intended to aid in the detection of periapical radiolucency on permanent teeth captured on maxillofacial Cone Beam CT images, only in patients where a dental professional determined such images to be necessary to evaluate possible dental abnormalities and where the dental professional has the appropriate knowledge and training to interpret and assess maxillofacial Cone Beam CT images. The device provides additional aid for the dental professional to use in their identification of periapical radiolucency. The device is not intended as a replacement for a complete dental professional’s review or their clinical judgment that considers other relevant information from the patient or other images or patient history. The system is to be used by professionally trained and licensed dental professionals. Diagnocat is indicated for use by dental professionals for the second-read of CBCT radiographs of permanent teeth in patients 22 years of age or older.
• 00860010268063 - Diagnocat: 2026-02-06 Diagnocat software is a radiological, automated, concurrent read computer-assisted detection software intended to aid in the det
• 00860010268087 - Segmentron Viewer: 2026-02-06 Segmentron Viewer is a software product intended for processing and manipulating maxillofacial radiographic images. Segmentron