510(k) Registered.
digitalhumanOS™ is 510(k) registered for multimodal clinical screening. 510(k) registration means the platform has been reviewed by the FDA for substantial equivalence, providing health systems with regulatory confidence for clinical deployment.
Key Facts
- Registration
- 510(k)
- Classification
- Clinical AI
- Conditions
- 46
- Compliance
- HIPAA
- Deployment
- Samsung Knox
510(k) registered. HIPAA compliant. Human-in-the-loop by design. Because trust in healthcare is not a feature. It is a prerequisite.
What 510(k) Registration Means for Your Health System
510(k) is an FDA premarket notification that demonstrates a medical device is substantially equivalent to a legally marketed predicate device. For health systems, it means the screening platform has been reviewed by the FDA for substantial equivalence, providing a level of regulatory oversight that most clinical AI does not have.
Most clinical AI operates without regulatory oversight. 510(k) registration is the dividing line between platforms that have been reviewed by the FDA and those that have not.
Peer-Reviewed. Clinically Validated.
Our screening models aren't validated on curated lab data. They are validated against real clinical outcomes from real patients in real care settings. Depression screening at 81.6% accuracy (Journal of Affective Disorders). PTSD at 80.0% (Journal of Traumatic Stress). Anxiety at 77.5% (Psychological Medicine). Parkinson's at an AUC of 0.97 (Movement Disorders). These numbers come from peer-reviewed clinical research — not marketing claims.
Safety Is Not a Feature. It Is the Foundation.
GIA®, powered by digitalhumanOS™, is a screening agent — not a diagnostic tool. She flags potential conditions for clinician review. Every result is reviewed by a qualified healthcare provider before any clinical action is taken. The system assists clinical judgment. It never replaces it.
Screening, Not Diagnosis
Every flagged condition requires clinician confirmation. The system identifies what needs attention — the clinician decides what to do about it.
Continuous Monitoring
Model performance is monitored continuously against real-world outcomes. Accuracy doesn't degrade because we catch it before it does.
Transparent Methodology
Our clinical validation methodology, accuracy metrics, and limitations are published and peer-reviewed. We don't ask for trust. We earn it.