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
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
Malaysia Board Approval
Augmento and CXR Analyzer received approval from Malaysia MDA
CE Mark
Augmento obtained self-declared CE marking as class I SaMD per EU MDR 2017/745
MoH Indonesia Approval
Augmento has received approval from Indonesia MoH
HSA Approval
Chest X-ray AI solution received approval from Singapore HSA
EU CE MDR Approval
Chest X-ray AI solution received CE approval as class IIb SaMD per EU MDR 2017/745
Philippines FDA Approved
For Augmento and Chest X-Ray AI Solution
UK - Ministry of Healthcare Products Regulatory Agency
Augmento and CXR AI Solutions are now registered with UK MHRA
Ayushman Bharat Health Account Compliant
Augmento Enterprise is now ABHA (Ayushman Bharat Health Account) compliant and integrated with the Ayushman Bharat Digital Mission (ABDM)
Management System Certifications
DeepTek's Quality System is EN ISO 13485:2016 certified
DeepTek's Information Security Management System is ISO 27001:2022 certified
Medical device standards/regulations that DeepTek.ai conforms to :
EN ISO 13485:2016
Quality management systems
21 CFR Part 820
US FDA QSR
EU MDR 2017/745
European Medical Device Regulation
ISO 14971:2019
Risk management
ISO/TR 24971:2020
Risk guidance supplement
IEC 62304:2006/Amd 1:2015
Software lifecycle processes
IEC 82304-1
Health software safety/security
IEC 62366-1:2015/Amd 1:2020
Usability engineering
AAMI TIR57
Cybersecurity risk management
IMDR 2017
Indian regulation
HIPAA (USA)
Health data privacy/security