FDA 510(k) Cleared · K24382144 AI dental devices cleared · 2021–2025

THE SCAN
READS ITSELF.

Machine vision reads panoramic X-rays, periapicals, and CBCTs in under four seconds — painting every fracture, lesion, and missed canal directly onto the image.

DIAGNOSE · PANORAMIC ANALYSIS
Analysis Complete · 3.8s
Patient Queue
Sarah M.
9:02 AM
David K.
9:18 AM
Lisa T.
9:34 AM
James R.
9:50 AM
Anna W.
10:06 AM
Full-arch panoramic dental radiograph showing teeth with AI-detected pathologies highlighted
97.3%
91.8%
94.6%
#14 — Mesial Carious Lesion97.3%
#19 — Vertical Root Fracture91.8%
#30 — Periapical Radiolucency94.6%
FDA 510(k) ClearedHIPAA Compliant3.8s AnalysisPanoramic · Periapical · CBCT97%+ Detection AccuracyHL7 IntegrationZero Missed LesionsDentrix · Eaglesoft · Open DentalFDA 510(k) ClearedHIPAA Compliant3.8s AnalysisPanoramic · Periapical · CBCT97%+ Detection AccuracyHL7 IntegrationZero Missed LesionsDentrix · Eaglesoft · Open Dental
01 — Accuracy
97.3%

Sensitivity on mesial carious lesions. Across all pathology types, Diagnose reads at or above the 91st percentile of specialist radiologists.

Without Diagnose
Raw dental panoramic X-ray without AI annotation, showing undetected pathologies
No Annotations
Average read time: 4–8 minutes
1 in 4 carious lesions missed on panoramic
Vertical root fractures: 60% detection rate
No confidence scoring or audit trail
Missed diagnosis: avg $65,000 settlement
With Diagnose
Dental panoramic X-ray with AI annotation showing cyan bounding boxes on detected pathologies
97.3%
91.8%
+Analysis complete in 3.8 seconds
+97%+ sensitivity on carious lesions
+Vertical root fractures: 91% detection
+Confidence % + full DICOM audit trail
+Every finding documented before loupes down
Detection Accuracy by Pathology

Live Benchmark Table

Pathology
Sensitivity
Specificity
Modality
Mesial Carious Lesion
97%
96%
Panoramic
Periapical Radiolucency
94%
97%
Periapical / CBCT
Vertical Root Fracture
91%
95%
CBCT
Periodontal Bone Loss
93%
94%
Panoramic
Missing Root Canal
96%
98%
Periapical
Impacted Third Molar
99%
99%
Panoramic

Accuracy benchmarked against board-certified oral radiologists. All figures peer-reviewed, 2024–2025 clinical studies.

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02 — Speed
0.0
secondsfull analysis

Your Tuesday schedule has 40 patients. A radiologist reading without AI averages 6 minutes per scan. Diagnose reads all 40 before your first patient is seated.

Without Diagnose
Manual read per scan4–8 min
40-patient Tuesday3.3 hrs
Missed findings per day8–12
Documentation lag2+ hrs
With Diagnose
AI analysis per scan3.8s
40-patient Tuesday2.5 min
Missed findings per day0–1
Documentation lag0 min
3.8-Second Breakdown
0ms
DICOM ingested
400ms
Preprocessing
1.2s
Tooth segmentation
2.6s
Pathology detection
3.8s
Annotations rendered

Speed benchmarked on AWS c6i.4xlarge. CBCT segmentation 3D adds 1.2s. Batch processing: 500 scans/hour.

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03 — Integrations
HL7

Diagnose plugs into Dentrix, Eaglesoft, and Open Dental via HL7 v2.8 — no middleware, no DICOM conversion, no IT project.

Without Diagnose
Export DICOM → re-import to viewer → annotate manually
Findings typed separately into chart notes
No structured data — unstructured text only
Average integration project: 3–6 months
IT dependency for every new imaging modality
With Diagnose
+Findings auto-pushed to patient chart via HL7
+Structured data: ICD-10 codes + confidence scores
+DICOM SR annotation files stored alongside image
+Setup time: 15 minutes with IT guide
+New modalities: enable in dashboard, no IT ticket

Dentrix

60,000+ practices
Live

Bi-directional HL7 v2.8 feed. Annotations appear in the patient chart the moment analysis completes.

Auto-chart findingsPerio charting syncTreatment plan push

Eaglesoft

30,000+ users
Live

Native Patterson imaging bridge. Diagnose findings surface inline with existing Patterson radiographs.

Patterson hardware supportOne-click installImaging module sync

Open Dental

Open source, zero lock-in
Live

REST API integration with full DICOM pass-through. Community-maintained connector, free forever.

REST APIDICOM passthroughCommunity connector

Carestream

Carestream CS imaging suite
Beta

Reads CS 3D CBCT exports directly. No DICOM conversion required.

CS 3D nativeNo conversionAuto-export
Sample HL7 v2.8 — Diagnose Finding Payload
MSH|^~\&|DIAGNOSE|AI_ENGINE|DENTRIX|PRACTICE|20260227122402||ORU^R01|MSG001|P|2.8
PID|1||PT-48291^^^PRACTICE||Chen^Wei||19881104|M
OBR|1||RAD-2026-1847|PANORAMIC^FULL ARCH|||20260227122358
OBX|1|ST|FINDING^CARIOUS_LESION||#14 MESIAL D1||CONFIDENCE:0.973|H|||F
OBX|2|ST|FINDING^PERIAPICAL_RADIOLUCENCY||#30 APICAL||CONFIDENCE:0.946|H|||F
OBX|3|ST|FINDING^VERTICAL_ROOT_FRACTURE||#19 MID-ROOT||CONFIDENCE:0.918|H|||F
OBX|4|NM|ANALYSIS_TIME^SECONDS||3.8|s|||F

Also integrates via FHIR R4, DICOM SR, and direct REST API. Webhook support for custom EHR builds.

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04 — Compliance
510(k)

Three FDA clearances covering every modality you read. Class II SaMD. The only dental AI platform cleared for panoramic, periapical, and CBCT in a single subscription.

Without Diagnose
Unaided reads: no audit trail for missed pathology
Malpractice exposure: avg $65,000 per missed diagnosis
Failure to diagnose = highest settlement category
No structured documentation of radiographic review
DSO clinical directors: no floor-level consistency data
With Diagnose
+FDA-cleared Class II SaMD — 3 modality clearances
+Every scan: timestamped DICOM SR + finding log
+HIPAA-compliant: BAA included, AES-256 at rest
+SOC 2 Type II certified infrastructure
+DSO dashboard: per-provider diagnostic consistency score
510(k) Number
Device
Date Cleared
Pathway
K243821
Panoramic CADe
Nov 2024
510(k)
K241205
Periapical CADe
Mar 2024
510(k)
K240887
CBCT Segmentation
Jan 2024
510(k)
FDA 510(k) Class II
HIPAA Compliant
SOC 2 Type II
DICOM SR Certified
AES-256 Encryption
BAA Included
HL7 v2.8 Certified
ISO 13485

BAA executed at signup. All PHI processed in US-East-1 and US-West-2 AWS regions. No PHI leaves US jurisdiction.

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05 — Pricing
$0.42

Cost per scan on the Practice plan. The average dental malpractice settlement for a missed diagnosis is $65,000. One prevented claim pays for 154,761 scans.

The Risk Without Diagnose
Avg malpractice settlement
$65,000
Failure-to-diagnose: % of cases
6%
Highest dollar category per MedPro Group
Manual read cost (radiologist)
$18–$45
Per scan, outsourced teleradiology
With Diagnose
Cost per scan (Practice plan)
$0.42
Scans to offset one claim
154,761
At $0.42/scan vs $65K settlement
Vs. teleradiology outsource
97% less
Diagnose at $0.42 vs $18–$45 outsourced
Solo provider

Associate

$299/mo
$0.75/scan · 400 scans/mo
+Panoramic + Periapical
+Real-time annotations
+DICOM SR audit trail
+HL7 integration (1 PMS)
+HIPAA BAA included
+Email support
Start Free Trial
Most Popular
2–8 providers

Practice

$899/mo
$0.42/scan · 2,100 scans/mo
+Panoramic + Periapical + CBCT
+Real-time annotations
+DICOM SR + finding log
+HL7 integration (all PMS)
+HIPAA BAA + SOC 2
+Slack + email support
+Provider consistency dashboard
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Enterprise / multi-location

DSO

Custom
Volume pricing · Unlimited scans
+All modalities + batch processing
+Per-provider diagnostic floor reporting
+Custom HL7 / FHIR build
+Dedicated CSM
+SLA 99.99% uptime
+On-site training
+Custom BAA terms
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