FDA 510(k) · CE Mark · HIPAA Compliant

Reads scans faster
than your first coffee.

Pulmonary nodules, hairline fractures, tumor margins — flagged in milliseconds with sub-pixel precision. Built for radiology departments drowning in overnight backlogs.

pacs.diagnose.ai/workspace/case-4821
CT chest scan — raw grayscale
RAW · Chest CT · Axial
Patient: ANON-4821
Slice: 47 / 312
kVp: 120 · mAs: 200
CT chest scan — AI analysis overlay
AI OVERLAY · 3 findings
DICOM SR Export·HL7 FHIR Ready·PACS Integration
Live · 2026-02-27 05:29
Avg. Analysis Time1.2sper scan series
Sensitivity99.1%vs. 91.4% radiologist avg.
Critical Findings0missed in validation (n=42,000)
Scans Analyzed4.2M+across 180 institutions
Clinical Capability Matrix

Every modality.
Every finding.

MODALITY
CLINICAL FINDING
SENSITIVITY
SPECIFICITY
CLEARANCE
CITATIONS
DESCRIPTION
Chest CT
ROUTINE
Pulmonary Nodule Detection
99.1%
97.4%
FDA 510(k)
14
Sub-3mm nodule detection with Lung-RADS v1.1 classification
Brain MRI
URGENT
Intracranial Hemorrhage
98.7%
96.9%
FDA 510(k)
11
Multi-sequence hemorrhage classification with midline shift quantification
Musculoskeletal X-ray
ROUTINE
Hairline Fracture Detection
97.8%
95.2%
FDA 510(k)
9
Cortical disruption mapping across 27 anatomical sites
Abdominal CT
URGENT
Liver Lesion Characterization
96.3%
94.7%
CE Mark
8
LI-RADS 2018 scoring with volumetric tumor margin delineation
Mammography
CRITICAL
DCIS & Mass Detection
95.9%
93.1%
FDA 510(k)
17
Density-adjusted detection with BI-RADS automated reporting
Spine MRI
CRITICAL
Cord Compression Grading
98.2%
96.0%
CE Mark
6
Modified Pfirrmann grading with surgical urgency flagging
Performance metrics from prospective multi-site validation studies. N=42,000+ cases. Last updated Feb 2026.View full validation data
VALIDATION RESULT · NEJM 2025 · DOI: 10.1056/NEJMoa2024.4821
4.2M
scans analyzed. Zero missed critical findings in validation.
01 · TURNAROUND
< 2sper series

vs. 20–45 min radiologist queue time

02 · COVERAGE
180+institutions

across 14 countries, 3 continents

03 · BACKLOG REDUCTION
73%avg. reduction

overnight queue cleared before 6 AM

Integrates natively with
Epic
Cerner
Philips IntelliSpace
GE Centricity
Sectra PACS
Fujifilm Synapse
Intelerad
Ambra Health
Change Healthcare
Nuance PowerScribe
Epic
Cerner
Philips IntelliSpace
GE Centricity
Sectra PACS
Fujifilm Synapse
Intelerad
Ambra Health
Change Healthcare
Nuance PowerScribe
Clinical Validation

Trusted by the
departments that matter.

"We cleared a 340-scan overnight backlog before 5 AM. The radiologists walked in to a clean queue for the first time in three years."

340 scans cleared
per overnight shift
Dr. Marcus Webb, MD — Chief of Radiology at Northwestern Memorial Hospital
Dr. Marcus Webb, MD
Chief of Radiology
Northwestern Memorial Hospital

"The nodule detection sensitivity is genuinely better than our senior radiologists on high-volume screening days. That's not a claim — it's in our IRB data."

99.1% sensitivity
vs 91.4% baseline
Dr. Priya Venkataraman, MD, PhD — Director of Thoracic Imaging at Mayo Clinic — Rochester
Dr. Priya Venkataraman, MD, PhD
Director of Thoracic Imaging
Mayo Clinic — Rochester

"We run 12 time zones of reads. Diagnose scales the coverage without scaling headcount. It's the only AI tool that actually integrates with our Sectra PACS out of the box."

12 time zones
zero headcount increase
James Okafor — CIO at NightHawk Radiology Group
James Okafor
CIO
NightHawk Radiology Group
Deployed at leading institutions
Mayo ClinicCleveland ClinicJohns HopkinsMass GeneralUCSF Medical CenterNorthwestern MemorialCedars-SinaiNYU Langone
Get Started

Start your
clinical pilot.

Most pilots go live within 72 hours. No disruption to existing PACS workflow.

Request a Clinical Demo

Live walkthrough · Your data · Your PACS

Institutional email required. No Gmail / personal addresses.

HIPAA BAA signed at demo. No PHI required for pilot setup.

Download the Validation Whitepaper

48-page prospective study · 42,000 cases · peer-reviewed

Contents
Multi-site prospective validation (n=42,000)
Head-to-head vs. 6 board-certified radiologists
Sub-group analysis: rare pathology detection
PACS integration benchmarks across 8 systems
Regulatory pathway summary — FDA, CE, ANVISA
🔒
HIPAA
BAA available
✓
SOC 2
Type II certified
⚡
99.99%
uptime SLA