Diagnocat is a cloud-based dental AI platform that analyzes CBCT scans, intraoral X-rays and panoramic images, builds 3D models from CBCT and drafts reports for the dentist to review. The vendor says it detects more than 60 conditions on 3D scans and over 40 on 2D images, but its only FDA clearance (K252934, January 15, 2026) covers a single finding: periapical radiolucency on CBCT scans of permanent teeth in patients 22 and older.
Quick verdict
Diagnocat suits practices that already take CBCT scans and want AI help spotting periapical radiolucencies, plus 3D models, implant planning and patient-friendly reports in the same cloud account. The FDA clearance is narrow: 2D X-ray analysis and the other conditions the vendor advertises sit outside it. Published studies give mixed results: high sensitivity for periapical lesions on CBCT of molars, with moderate specificity, and lower sensitivity than experienced endodontists on 2D periapicals. Prices aren’t published, no PMS is named, and user reviews weren’t collected for this review. If you’re a US practice, ask the vendor which features you can use here before you sign.
Diagnocat at a glance
| Vendor | Diagnocat (the FDA record lists the applicant as DGNCT, LLC) |
|---|---|
| What it does | AI reports on CBCT, intraoral and panoramic images; 3D models and CBCT-to-intraoral-scan superimposition; implant and orthodontic reports; PMS integration; Transcriptor consultation notes |
| Who it’s for | Single practitioners, clinics, laboratories and diagnostic centers (the vendor’s own groups) |
| Pricing | Pricing on request; the vendor says plans are subscriptions paid monthly or annually (checked October 19, 2026) |
| FDA status | FDA 510(k) cleared, K252934 (January 15, 2026), for periapical radiolucency on CBCT only |
| HIPAA / BAA | The vendor’s FAQ says it offers “HIPAA and PIPEDA-compliant cloud storage for medical data.” The pages we read don’t mention a BAA. |
| Integrations | The vendor says it connects to X-ray equipment through its paid Diagnocat Imaging app and to your PMS through a custom integration. No PMS or imaging product is named. |
| Data checked | October 19, 2026 |
What is Diagnocat?
You upload a CBCT scan or a 2D X-ray to Diagnocat, or have it sent automatically, and its cloud AI turns the images into structured reports, 3D models and charts for the dentist to check. The vendor says the radiological report covers “more than 60 clinical conditions in 3D.”
The vendor now markets the whole suite as Diagnocat 360, which it calls “One AI platform for the whole case.” Its home page says the platform connects to your clinic’s information system, X-ray equipment and intraoral scanners so that patient data lives in one interface. It also says dental and periodontal charts “complete automatically” and that Transcriptor “records, transcribes, and analyzes every consult.”
Setup, as the vendor describes it, takes two weeks: onboarding on day 1, connecting your PMS and imaging equipment on days 2 to 7, a pilot and training on real cases on days 8 to 13, and go-live on day 14.
Diagnocat’s saved pages don’t give a company address. The site’s region menu lists the USA alongside DACH, Spain, Italy, other EU countries, the UK, Canada, South Africa and Oceania. Every page ends with the same notice: features “may not be available or approved for use in all regions,” regulatory clearance “varies by country,” and you should contact the company to confirm availability in your region. The FDA’s 510(k) summary lists the submitter as DGNCT LLC with a Miami, Florida address.
Key features
Diagnocat’s main features are AI image reports, 3D models, implant and orthodontic planning, PMS integration and a consultation transcriber, as the vendor’s product pages describe them:
- Radiological report: AI analysis of intraoral X-rays, panoramic X-rays (OPGs) and CBCT scans; the vendor says over 40 conditions on 2D and over 60 on 3D
- Patient-friendly, print-ready reports: visual reports the vendor says help explain findings to patients; you can add your clinic’s logo, contact details, signature and seal
- 3D models: automatic segmentation of CBCT scans into STL models (teeth, jaws, canals, sinus, soft tissue and other structures), including pulp and root canal filling material
- Superimposition: automatic matching of CBCT data with intraoral scans, with export for digital planning software
- Implant report: 3D implant planning with automatic tracing of the mandibular canal, a library of implant systems and surgical guides downloadable as STL files; the vendor says the AI proposes an implant position that the doctor can adjust
- Orthodontic report: an analysis of the dentoalveolar complex based on CBCT data
- Analytics and reporting: business analytics for managers, and a Morning Huddle report that combines Diagnocat data with your clinic’s daily plan
- Transcriptor: records and transcribes consultations and produces SOAP-format notes, a communication assessment based on the Calgary-Cambridge model and a letter for the patient; it needs a pair of wireless microphones
The Transcriptor page claims documentation time is reduced by up to 75% and lists “Conversion to treatment plan: up to 15%”. Both figures are footnoted as based on Diagnocat reference clinics and internal evaluation, so treat them as the vendor’s own numbers.
The FAQ says there’s no limit on the number of users per clinic, the whole team can work at the same time, and Google Chrome is the recommended browser. CBCT uploads must be .dcm (DICOM) files and 2D images .jpg, .png or .tiff, with a 2 GB limit per image. For the 3D module, the vendor gives a 20 Mbit/sec minimum internet speed and recommends 50 Mbit/sec.
Diagnocat vs. what an imaging AI tool should have
Diagnocat covers CBCT analysis, patient-facing reports and practice analytics, and its FDA indication makes the dentist’s review explicit. The gaps are FDA coverage for what it advertises (only one finding on CBCT is cleared), no named PMS or imaging products, no BAA on the pages we read and no public pricing.
Must have
| Feature | Status | Note |
|---|---|---|
| FDA clearance for each advertised finding | Partial | Periapical radiolucency on CBCT is cleared (K252934); the other advertised conditions and all 2D analysis are not in the indication |
| Works with your imaging software or sensors | Listed | Paid Diagnocat Imaging app uploads images from your X-ray computer; no imaging product named |
| Works with your practice management system | Partial | The vendor says a custom integration transfers images and patient data and fills dental and perio charts; no PMS named |
| Dentist reviews every finding | FDA listing | Concurrent-read aid for second-read; not a replacement for the dental professional’s review or clinical judgment |
| Image types covered | Partial | FDA: CBCT only. The vendor lists intraoral, panoramic and CBCT |
| Data protection details | Partial | The FAQ claims HIPAA and PIPEDA-compliant cloud storage; no security page or BAA in the pages we read |
Should have
| Feature | Status | Note |
|---|---|---|
| Published study that names the product | Study | 25 PubMed records name Diagnocat; six are summarized below |
| Patient-facing view for chairside explanations | Listed | Visual, print-ready patient reports |
| Pediatric use covered | Not listed | The FDA indication is for patients 22 years of age or older |
| Public pricing | Not listed | Subscription, monthly or annual; no prices published |
Nice to have
| Feature | Status | Note |
|---|---|---|
| CBCT analysis | FDA listing | K252934, periapical radiolucency on CBCT |
| Insurance and claims support | Not listed | |
| Practice analytics | Listed | Analytics & Reporting and the Morning Huddle report |
What the research says
A PubMed search for Diagnocat on October 19, 2026 found 50 records, and 25 of them name the product. Results depend on the image and the finding. On CBCT, one study found high sensitivity but moderate specificity for periapical lesions, and on 2D images the numbers swing from study to study.
None of the six PubMed records lists a Diagnocat affiliation for any author, though the secondary caries comparison study’s record lists no affiliations at all. Five of the six are retrospective, and three use images from a single practice or clinic. Their numbers can’t be compared directly.
Periapical radiolucencies on CBCT of molars (Journal of Dentistry, 2025). Researchers at King’s College London and Taif University analyzed preoperative and postoperative CBCT scans of 134 molars (327 roots), with two experienced endodontists as the reference. In preoperative scans of non-root-filled molars, Diagnocat’s sensitivity was 93.9% at the tooth level and 86.2% at the root level, and specificity was 65.2% and 79.9%. The AUC was 0.76 for teeth and 0.79 for roots. On postoperative scans, positive predictive value fell to 54.2% for teeth and 46.9% for roots. The authors say the moderate specificity means a clinician needs to check the output to prevent overdiagnosis.
Endodontic findings on CBCT (Journal of Clinical Medicine, 2026). Authors from two German private practices and Martin-Luther-University Halle-Wittenberg evaluated 358 root-canal-treated teeth from 167 CBCT scans at a single private dental practice. Of the 383 teeth first included, the AI recognized 358 (93.5%). AUC ranged from 0.984 for missed canals to 0.761 for voids in the root filling, with 0.864 for apical lesions. Apical-lesion sensitivity was 33.6% for sub-millimeter lesions and at least 80% for lesions of 1 to 5 mm. The authors call it a focused screening adjunct and say sub-millimeter apical lesions remain outside its reliable range.
Apical radiolucencies on 2D periapicals (International Endodontic Journal, 2025). The King’s College London group compared Diagnocat with two experienced endodontists on periapical radiographs of 339 teeth (796 roots), using CBCT read by two other endodontists as the reference. The clinicians were more accurate at the tooth level (86.1% vs. 78.5%) and more sensitive (65.3% vs. 47.9%); specificity was comparable (97.7% vs. 95.4%). This use, on 2D images, is outside the FDA clearance.
Caries on bitewings (Clinical Oral Investigations, 2026). Researchers from Cyprus, Greece and the UAE tested Diagnocat on 100 digital bitewings (1,540 surfaces) from the European University Cyprus dental clinic database, against two experts. Specificity was 94.3%, negative predictive value 96.1% and overall accuracy 91.6%. Sensitivity was moderate at 73.1%, and positive predictive value was 64.7%. The authors conclude it is good at ruling out caries and that its lower sensitivity calls for clinician oversight.
Secondary caries, five commercial tools compared (Caries Research, 2026). A cross-sectional study of 200 anonymized bitewings (885 restored tooth surfaces) tested Diagnocat alongside four other commercial systems, including Second Opinion and CranioCatch, and three experimental systems. Across all of them, specificity was high (0.957 to 0.986) and sensitivity moderate (0.327 to 0.487). Accuracy ranged from 0.882 to 0.917, and the abstract reports no statistical difference between systems. The abstract doesn’t say where the images came from. This use, caries on 2D bitewings, is outside the FDA clearance, and the same applies to the Clinical Oral Investigations study above.
Treatment features on CBCT (Diagnostics, 2025). A retrospective single-center study from Poland ran 147 CBCT scans (4,704 tooth positions) through Diagnocat to detect missing teeth, fillings, endodontic treatments, crowns, implants and similar features. Tooth-level accuracy exceeded 99% for most categories, but only 82.3% of scans had an entirely error-free full-mouth report. The authors say it works best as an assistive tool, not an autonomous system.
Both the Diagnostics 2025 and Journal of Clinical Medicine 2026 studies use CBCT, but apart from periapical lesions, the findings they test aren’t part of the FDA clearance.
The FDA’s 510(k) summary also reports the vendor’s own testing. In 285 CBCT images, sensitivity for periapical radiolucency was 0.854 and specificity 0.991. In a multi-reader study, readers’ average AUC rose from 0.8940 unaided to 0.9213 with Diagnocat. The summary doesn’t say where the images came from.
FDA status and privacy
Diagnocat has one FDA clearance: 510(k) K252934, decided January 15, 2026, for the device named Diagnocat, with DGNCT, LLC as applicant. The FDA describes it as computer-assisted detection software to aid in the detection of periapical radiolucency on permanent teeth captured on maxillofacial CBCT images. We found no premarket approval listing under the Diagnocat name (searched October 19, 2026).
| Device | 510(k) | Cleared | What the FDA summary says it does |
|---|---|---|---|
| Diagnocat | K252934 | January 15, 2026 | Aids detection of periapical radiolucency on permanent teeth on CBCT images, as a second read, for patients 22 and older |
The indication comes with limits worth reading closely. The FDA says Diagnocat may be used only when a dental professional has independently decided that CBCT imaging is necessary, on scans taken for clinically justified purposes. It is meant for licensed dental professionals with at least two years of clinical experience reading CBCT scans. And the device “is not intended as a replacement for a complete dental professional’s review or their clinical judgment.” Every AI mark is a suggestion, and the dentist decides whether it’s real.
The predicate device in the 510(k) summary is Overjet Periapical Radiolucency Assist, which works on 2D X-rays. The vendor’s other products, including 2D analysis, 3D models, implant and orthodontic reports, and Transcriptor, aren’t part of this clearance.
On privacy, the vendor’s FAQ says Diagnocat “offers HIPAA and PIPEDA-compliant cloud storage for medical data” and that storage duration follows the law of the country where the service is bought and used. The clinics page mentions patient sharing “with multi-level security and confidentiality.” The pages we read name no security certification and no BAA, so ask for a signed BAA before you upload patient images.
Pricing
Pricing on request (checked October 19, 2026). Diagnocat’s FAQ says access is a subscription paid monthly or annually, with plans depending on the services you need and how often you use them. There is no pay-per-report option.
Before you call, know a few terms from the FAQ. Unused reports don’t carry over to the next subscription period; the FAQ’s example is a plan with 30 CBCT reports a month. Subscriptions renew automatically, and you can cancel from the account’s pricing section and keep access until the period ends. The Diagnocat Imaging app for automatic uploads is a paid add-on. And the vendor says a coming update will add a fee for storing large amounts of data without an active paid subscription.
Who it’s for
Diagnocat fits practices that take CBCT scans and want AI help finding periapical radiolucencies, along with 3D models, implant planning and patient reports from the same scans. The vendor also sells it to clinics, laboratories and diagnostic centers.
It’s a weaker fit if you mostly take bitewings and periapicals and want FDA-cleared AI for those images: Diagnocat’s clearance doesn’t cover 2D. It also isn’t cleared for patients under 22, and the FDA indication expects users with at least two years of CBCT reading experience. If you need a vendor to name your exact PMS and imaging software, or want published prices, you’ll have to ask.
FAQ
Is Diagnocat FDA cleared?
Yes, for one use. The FDA cleared Diagnocat under 510(k) K252934 on January 15, 2026, to aid detection of periapical radiolucency on CBCT images of permanent teeth in patients 22 and older. The 2D X-ray analysis and the other conditions the vendor advertises aren’t in that indication.
How much does Diagnocat cost?
Pricing on request. The vendor says plans are subscriptions paid monthly or annually, there is no pay-per-report option, and unused reports don’t roll over (checked October 19, 2026).
How accurate is Diagnocat?
It depends on the image type and the finding. A 2025 study of CBCT scans of 134 molars found 93.9% tooth-level sensitivity and 65.2% specificity for periapical lesions. On 2D periapicals, a 2025 study of 339 teeth found it less sensitive than experienced endodontists (47.9% vs. 65.3%).
Does Diagnocat replace the dentist’s reading of a scan?
No. The FDA indication describes a concurrent-read aid for a second read and says the device is not intended as a replacement for a complete dental professional’s review or clinical judgment. The dentist confirms or rejects every finding.
Is Diagnocat available in the US?
The vendor’s site lists the USA in its region menu, and the FDA has cleared one use. Each page also says features may not be available or approved in all regions and asks you to contact the company to confirm, so ask which features you can use in the US.
Does Diagnocat work with my PMS and X-ray software?
The vendor says a custom integration moves images and patient data between Diagnocat and your PMS and fills dental and perio charts, and a paid Diagnocat Imaging app uploads images from your X-ray computer. No PMS or imaging product is named on the pages we read, so confirm yours before you sign.
How this review was put together
We didn’t use Diagnocat ourselves. This review is built from 10 Diagnocat web pages (home, products, integration, 3D models and superimposition, implant report, Transcriptor, clinics, laboratories, FAQ and partner events), the FDA’s 510(k) and premarket approval databases and the K252934 decision document, and studies found in PubMed with the search term “Diagnocat”. User reviews weren’t collected for this review. All sources were checked on October 19, 2026.
Sources
- Diagnocat: home page, accessed October 19, 2026
- Diagnocat: products, accessed October 19, 2026
- Diagnocat: integration with practice management systems, accessed October 19, 2026
- Diagnocat: 3D models and superimposition, accessed October 19, 2026
- Diagnocat: implant report, accessed October 19, 2026
- Diagnocat: Transcriptor, accessed October 19, 2026
- Diagnocat for clinics, accessed October 19, 2026
- Diagnocat for laboratories and diagnostic centers, accessed October 19, 2026
- Diagnocat: FAQ, accessed October 19, 2026
- Diagnocat: partner events (region menu and regional notice), accessed October 19, 2026
- FDA 510(k) K252934, Diagnocat, accessed October 19, 2026
- FDA decision letter and 510(k) summary, K252934, accessed October 19, 2026
- openFDA device databases, 510(k) and premarket approval (search for Diagnocat), accessed October 19, 2026
- PubMed search: Diagnocat[tiab], accessed October 19, 2026
- Diagnostic accuracy of an artificial intelligence-based platform in detecting periapical radiolucencies on cone-beam computed tomography scans of molars, Journal of Dentistry (2025), accessed October 19, 2026
- Diagnostic Performance of AI-Based Cloud Software Regarding the Detection of Endodontic Findings on CBCT, Journal of Clinical Medicine (2026), accessed October 19, 2026
- The detection of apical radiolucencies in periapical radiographs: a comparison between an artificial intelligence platform and expert endodontists, International Endodontic Journal (2025), accessed October 19, 2026
- Evaluating AI diagnostic accuracy in approximal dental caries detection on bitewing radiographs, Clinical Oral Investigations (2026), accessed October 19, 2026
- AI-Based Clinical Decision Support Systems for Secondary Caries Detection and Staging on Bitewings, Caries Research (2026), accessed October 19, 2026
- AI-Based Detection of Dental Features on CBCT: Dual-Layer Reliability Analysis, Diagnostics (2025), accessed October 19, 2026
