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.

Solution Certifications

US FDA Cleared

Augmento obtained US FDA 510(k) clearance in April, 2023

CXR Analyzer obtained 510(k) clearance in October, 2023

CDSCO Approved

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

Regulatory

Augmento - AI-powered Radiology Workflow Management Solution received US FDA 510(k) Clearance

Systems and methods for selection of priority-wise artificially intelligent mechanisms per one or more characteristics

Application No.: 202321010405

Developed in accordance with IEC 62304 : 2006

(Medical device software — Software life cycle processes)

ISO/IEC 27001 : 2013 certified

(Information Security Management)

Medical device standards/regulations that DeepTek.ai conforms to :
  • EN ISO 13485:2016-  Medical devices - Quality management systems - Requirements for regulatory purposes
  • 21 CFR Part 820- Code of Federal Regulation Title 21- Quality System Regulation
  • ISO 14971:2019- Medical devices - Application of risk management to medical devices.
  • ISO/TR 24971:2020- Medical devices—Guidance on the Application of ISO 14971
  • IEC 62304:2006/Amd 1:2015- Medical device software— Software life cycle processes—Amendment 1
  • IEC 82304-1 Health software product safety and security requirement
  • IEC 62366-1:2015/Amd 1:2020- Medical devices - Application of usability engineering to medical devices—Amendment 1
  • AAMI TIR57 Medical device cybersecurity risk management
  • IMDR 2017- Indian Medical Devices Rule 2017
  • USA HIPAA Privacy and Security Rules for health data