PrognosiX Data Contribution Partnership
Help us revolutionize dental imaging with FDA-approved AI technology
Complete Agreement
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Advancing Dental AI Technology
Join Our FDA 510(k) Clinical Data Initiative
Partner with Prahsys to contribute dental imaging data that will help bring FDA-approved AI enhancement technology to the dental community. Your contribution will directly support the regulatory approval of PrognosiX, our groundbreaking dental imaging analytics solution.
Your Contribution
Provide 100 dental imaging exams with representative anatomical views (upper/lower arches, anterior/posterior regions, bitewing and periapical images)
HIPAA Compliance
All data handling follows strict HIPAA requirements with de-identification per 45 C.F.R. § 164.514. Business Associate Agreement required.
Data Usage
Your data will be used exclusively for training, validating, and improving PrognosiX for FDA 510(k) submission and regulatory compliance
Legal Protection
You retain ownership of original data. Comprehensive indemnification and liability protections included in the agreement.
Ready to Partner With Us?
Complete the Data Contribution Agreement electronically through DocuSign
Agreement Overview
The Data Contribution and License Agreement establishes:
Scope
Contribution of 100 dental imaging exams by October 31, 2025
License
Non-exclusive, royalty-free license for regulatory use
Privacy
Full HIPAA compliance with data de-identification
Ownership
You retain ownership of original data
Term
Until 510(k) process completion or 30-day termination notice
Governing Law
Texas state law, Montgomery County jurisdiction
Data Contribution Deadline:
October 31, 2025
Benefits of Partnership
Early access to cutting-edge dental AI technology
Contribute to advancing the entire dental profession
Support FDA approval of innovative diagnostic tools
Recognition as an early adopter of AI-enhanced dentistry
Potential future collaboration opportunities
Requirements & Prerequisites
Must have existing Business Associate Agreement (BAA) with Prahsys or execute one concurrently
Legal authority to contribute patient imaging data for research purposes
Required patient consents, authorizations, or regulatory exceptions in place
Imaging data must meet Prahsys quality and format specifications
Ability to securely transfer data per HIPAA requirements
