Doctors discussing Regulatory approvals like US FDA, CE
DeepTek's solutions meet the highest regulatory requirements like US FDA and CE Mark

At DeepTek.ai 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 has obtained EN ISO 13485:2016 certification that ensures our medical devices meet all quality requirements.

We are 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 global security standards and regulations such as ISO 27001, GDPR, and HIPAA attests to this commitment.

Solution Certifications

Augmento and CXR Analyzer are US FDA 510(k) cleared

US FDA Cleared

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

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

CDSCO Clearance for Genki and Augmento

CDSCO Approved

DeepTek obtained MD-42 Sale & Distribution license

Manufacturing License for Genki and Augmento

Genki and Augmento are Kenya Board Certified

Kenya Board Certified

Genki and Augmento is Kenya Board Certified

Genki obtained Thai FDA Approval

Thai FDA Approved

Genki obtained Thai FDA Approval in May, 2023

Malaysia MDA approved Augmento and CXR Analyzer

Malaysia Board Approval

Augmento and CXR Analyzer received approval from Malaysia MDA

Augmento Enterprise has obtained CE marking

CE Mark

Augmento obtained self-declared CE marking as class I SaMD per EU MDR 2017/756

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MoH Indonesia Approval

Augmento has received approval from Indonesia MoH

HSA

HSA Approval

Chest X-ray AI solution received approval from Singapore HSA

CE MDR Approved

EU CE MDR Approval

Chest X-ray AI solution received CE approval as class IIb SaMD per EU MDR 2017/756

Management System Certifications

Augmento and CXR Analyzer are US FDA 510(k) cleared

DeepTek's Quality System is EN ISO 13485:2016 certified

CDSCO Clearance for Genki and Augmento

DeepTek's Information Security Management System is ISO 27001:2022 certified

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
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