top of page

AI Solutions: Certified and Market Ready

The list below includes solutions that have obtained at least one certification from any issuing authority.

​

This site attempts to document and display regulatory approvals. However, it is important to understand the differences in regulatory classifications and approvals from non-stringent in-country regulators as they reflect the depth of testing, post-market surveillance, as well as the ability to support end users.

DeepTek Inc.

Certification:

US FDA 510(k) clearance, CE Class IIb, Indian CDSCO + 5 others

Development:

On the Market

Intended Age Group

4+ Years

InferVision

Certification:

CE Class IIb

Development:

On the Market

Intended Age Group

16+ Years

MEDICAL IP Co., Ltd.

Certification:

Korean MFDS Approved (overseas market only)

Development:

On the Market

Intended Age Group

15+ Years

Qure AI

Certification:

CE Class IIb MDR (qXR v4.1), US FDA Breakthrough Device + 9 others

Development:

On the Market

Intended Age Group

3+ Years

Vuno Inc

Certification:

CE MDD v1.1, CE MDR v1.2(2025.02), Korea MFDS v1.2, + 3 others

Development:

On the Market

Intended Age Group

19+ Years

Delft Imaging Systems

Certification:

v7: CE Class IIb certified from 4 ages and above / v8: pending CE receipt

Development:

On the Market

Intended Age Group

4+Years

JF Healthcare

Certification:

China NMPA Class III

Development:

On the Market

Intended Age Group

15+ Years

Nexus Intelligence (Pty) Ltd

Certification:

CE IIb; ISO 13485

Development:

On the Market

Intended Age Group

15+Years

RadiSen

Certification:

CE-Marked Class IIa

Development:

On the Market

Intended Age Group

16+ Years

Envision IT

Certification:

SAHPRA, US FDA 510(k) clearance , ISO 13485:2016

Development:

On the Market

Intended Age Group

6+ Years

JLK

Certification:

CE-marked Class Ⅰ, Japan PMDA

Development:

On the Market

Intended Age Group

10+ Years

Oxipit

Certification:

ChestEye: CE Class IIb, ChestLink: CE Class IIb

Development:

On the Market

Intended Age Group

18+ Years

Rayscape / Mindfully Technologies SRL

Certification:

CE Marked Class I, CE MDR class IIa (pending), ISO 13485

Development:

On the Market

Intended Age Group

16+ Years

Hangzhou Hanwei Health Technology Co., Ltd.

Certification:

China Medical Device Registration Certificate (NMPA)

Development:

On the Market

Intended Age Group

15+ Years

Lunit

Certification:

CE MDR Class IIa, Korea MFDS

Development:

On the Market

Intended Age Group

4+ Years (CE), 14+ Years (Korea)

Perceptra Company Limited

Certification:

Thai FDA Notification Certificate, HSA Singapore Authorization

Development:

On the Market

Intended Age Group

15+ Years

Shenzhen Smart Imaging Healthcare (ZYing) Co., Ltd

Certification:

China NMPA Class II
China NMPA Class III (Pending)

Development:

On the Market

Intended Age Group

15+ Years

AI Solutions: Certification Pending

Certification:

Pending

Development:

On the Market

Intended Age Group

0+ Years

Certification:

Pending

Development:

On the Market

Intended Age Group

16+ Years

AI Solutions: Under Development

Certification:

Pending

Development:

Under Development

Intended Age Group

18+ Years

Certification:

Pending

Development:

Under Development

Intended Age Group

18+ Years

Certification:

Thai FDA (pending)

Development:

Under Development

Intended Age Group

18+ Years

Certification:

Pending

Development:

Under Development

Intended Age Group

18+ Years

© 2023 Stop TB Partnership and FIND

bottom of page