At DeepTek.ai - DeepTek we are committed to developing and providing high-quality Radiology AI solutions that are safe, effective, meet all applicable global regulations, and meet customer satisfaction.
Our Quality Management System for managing the company’s different operations is designed in accordance with the framework established by the FDA Quality System Regulation (21 CFR Part 820) and ISO 13485:2016. DeepTek.ai - DeepTek is in the process of obtaining EN ISO 13485:2016 certification that ensures our medical devices meet all quality requirements.
DeepTek.ai - DeepTek is committed to protecting patient and customer information. Our products and services are designed and developed with security as a high priority, and our compliance with various security standards and regulations attests to this commitment.
US FDA Cleared
Augmento obtained US FDA 510(k) clearance in April, 2023
CXR Analyzer obtained 510(k) clearance in October, 2023
DeepTek obtained MD-42 Sale & Distribution license
Manufacturing License for Genki and Augmento
Kenya Board Certified
Genki and Augmento is Kenya Board Certified
Thai FDA Approved
Genki obtained Thai FDA Approval in May, 2023
Application No.: 202321010405
(Medical device software — Software life cycle processes)
(Information Security Management)