- What it does: Diagnocat is a cloud-based AI platform that analyzes CBCT volumes, panoramic radiographs, and intraoral x-rays. It holds two FDA 510(k) clearances, both issued to DGNCT, LLC: K252934 (AI second read on CBCT for periapical radiolucency) and K251072 (Segmentron Viewer). Other platform capabilities are not covered by those clearances.
- Regulatory: 2 FDA 510(k) clearances (K252934, K251072)
- Pricing: From €499/year (Self-serve subscription, 6 or 12 months)
- Best fit: specialist, ortho, oral-surgery
Diagnocat is built around CBCT, and both of its US clearances are for CBCT: one flags periapical radiolucency (K252934), the other covers 3D viewing (K251072). Overjet and Pearl now have CBCT clearances too, but theirs cover segmentation and anatomy rather than a finding. Its 2D x-ray reports are not covered by a US clearance, so practices that mostly read bitewings and periapicals are better served by Overjet, Pearl or VideaHealth. It is also one of the few imaging AI vendors with prices on its website, which makes it easy to try without a sales call.
Diagnocat vs alternatives
Other imaging & diagnostics tools we track: Overjet (quote only, 12 FDA clearances), Pearl (quote only, 8 FDA clearances), Dentsply Sirona DS Core (quote only, 4 FDA clearances), Velmeni (quote only, 4 FDA clearances).
Is Diagnocat FDA cleared?
Yes. Diagnocat holds 2 FDA 510(k) clearances: K252934 (Jan 15, 2026) for concurrent-read detection of periapical radiolucency on permanent teeth in CBCT scans, for patients 22 and older.; K251072 (Sep 9, 2025) for segmentron Viewer: processing and 3D visualization of maxillofacial radiographic images; STL generation for educational purposes only.. Features outside those indications are not covered by the clearance.
| 510(k) | Device | Decision | Cleared for |
|---|---|---|---|
| K252934 | Diagnocat | Jan 15, 2026 | Concurrent-read detection of periapical radiolucency on permanent teeth in CBCT scans, for patients 22 and older. |
| K251072 | Segmentron Viewer | Sep 9, 2025 | Segmentron Viewer: processing and 3D visualization of maxillofacial radiographic images; STL generation for educational purposes only. |
What Diagnocat does
Imaging modalities: CBCT, panoramic, intraoral.
- CBCT segmentation and 3D model generation
- Structured radiology reports
- Reports for implant planning, orthodontics, and endodontics
- Consultation transcription (Transcriptor)
How much does Diagnocat cost?
Diagnocat pricing starts at €499/year (Self-serve subscription, 6 or 12 months). Diagnocat's subscribe page, including its US version, lists prices in euros. 2D Lite (FMX and panoramic reports only): €299 for six months or €499 a year. Specialist (adds CBCT, implant and ortho reports): €590 for six months or €990 a year, with 120 2D and 70 3D reports a year on the annual plan. Unused reports do not carry over, and these plans do not connect to your x-ray machine. Source: diagnocat.com, checked Oct 25, 2026.
- FDA-cleared AI second read on CBCT scans for periapical radiolucency (K252934)
- Lists self-serve plan prices on its website; most dental imaging AI vendors quote only after a demo
- Covers intraoral, panoramic, and CBCT imaging in one platform, with 3D models and STL export (STL cleared for educational use only)
- Newer to the US market than established competitors, with limited domestic clinical validation data
- No US clearance covers its 2D (bitewing, periapical, panoramic) findings
- Self-serve plans are priced in euros, do not connect to the x-ray machine, and unused reports expire at the end of each term
- CBCT integration workflow may require verification with your specific scanner manufacturer
Where it fits
- CBCT segmentation reports for implant placement and oral surgery
- Multi-modality pathology screening across panoramic, periapical, and bitewing images
- 3D cephalometric analysis for orthodontic treatment planning
What we have not verified
Diagnocat launched in the US in late 2025, and we have not independently evaluated the platform in a live clinical environment. The company has been active internationally since 2017, reports 1,000+ clinics in 54 countries, and has Health Canada clearance, but the US track record is short. Diagnocat says the platform offers PMS integration, but we have not independently confirmed which systems are supported beyond the CBCT scanner manufacturers (Dentsply Sirona, Vatech, Planmeca, Carestream) listed on their site. If you’re evaluating Diagnocat, ask their sales team specifically about compatibility with your practice management system and imaging workflow.
Common questions
What does Diagnocat integrate with?
Diagnocat lists integrations with Dentsply Sirona, Vatech, Planmeca, Carestream. Confirm compatibility with your exact practice management and imaging versions before signing.
Sources
Corrections and updates
- 2026-10-25: Added Diagnocat's published self-serve prices. Removed the claim that Overjet and Pearl lack CBCT analysis; both now hold CBCT clearances (K251514, K243989).
- 2026-10-21: Corrected to list both FDA 510(k) clearances (K252934 and K251072) and headquarters (Miami, FL).