# K252934: Diagnocat

- Pathway: 510(k) (Traditional)
- Applicant: Dgnct, LLC
- Decided: Jan 15, 2026 after 122 days
- Product code: MYN (Analyzer, Medical Image)
- Device class: 2
- Regulation: 21 CFR 892.2070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to P980025 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231678: Overjet Periapical Radiolucency Assist, Overjet, Inc. (2023) Summary page 5.

## Indications for use
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, using scans that were previously acquired for clinically justified purposes independent of Diagnocat. Diagnocat may be used only when a dental professional has independently determined that CBCT imaging is necessary for further evaluation of the patient. 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 with the appropriate knowledge and training to interpret maxillofacial CBCT images, including at least two years of clinical experience reading and assessing CBCT scans. 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.

Source page: https://510kreport.com/device/K252934
Methodology: https://510kreport.com/methodology