510(k) · Cleared
ClearedDiagnocat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dgnct, LLC · MYN Analyzer, Medical Image
Cleared on Jan 15, 2026 as substantially equivalent to K231678 (Overjet, Inc., 2023) after a 122-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Jan 15, 2026
- Review
- 122 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to P980025 (1998). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backP980025 Logicon Caries DetectorCarestream Dental, LLC · 1998 · Recalled
- 3 generations backK210365 Second OpinionPearl, Inc. · 2022
- 2 generations backK221921 DTX Studio Clinic 3.0Nobel Biocare AB · 2023
- 1 generation backK231678 Overjet Periapical Radiolucency AssistOverjet, Inc. · 2023
- This deviceK252934 DiagnocatDgnct, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P980025 | Logicon Caries Detector | Carestream Dental, LLC | 1998 | 1 |
| −3 | K210365 | Second Opinion | Pearl, Inc. | 2022 | — |
| −2 | K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2023 | — |
| −1 | K231678 | Overjet Periapical Radiolucency Assist | Overjet, Inc. | 2023 | — |
| 0 (this device) | K252934 | Diagnocat | Dgnct, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MYN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MYN device
- #1 K210365 Second Opinionscore 30.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231678 | Overjet Periapical Radiolucency AssistSummary page 5…ation Name: Medical Image Analyzer Regulatory Class: 21 CFR 892.2070 Product Code: MYN Predicate Device: Overjet Periapical Radiolucency Assist (K231678) Device Description Diagnocat Software is a computer-assisted detection (CADe) software-only device intended to concurrently ai… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K231678.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MYN
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYN
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYN
No recall names MYN since 2007.
Adverse event reports per year · MYN
2in 2025
MAUDE reports naming product code MYN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 6 | — | 0 | 0 |
| 2013 | 4 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 5 | 273 | 0 | 0 |
| 2023 | 10 | 229 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 14 | 210 | 0 | 2 |
| 2026 | 7 | 128 | 0 | — |
What is it indicated for?
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…
Read the full statement (177 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252934 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252934: Diagnocat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252934
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026