Regulatory Status by Market

Yes — Us2.ai is FDA 510(k) cleared. Us2.v1 was cleared in 2021 under K210791, and Us2.v2 was cleared in 2024 under K233676, expanding the cleared indication set. Both are Class II medical devices under 21 CFR 892.1560.

Yes — Us2.ai is CE marked as a Class IIb medical device under the EU Medical Device Regulation (MDR), certificate number 743947. The CE mark covers all EU member states, the UK (under MHRA registration), Iceland, Liechtenstein, Norway, and Switzerland.

Us2.ai is approved or registered in 28+ regulatory markets worldwide, including the US, EU, UK, Canada, Australia, New Zealand, Japan, Singapore, India, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Taiwan, Hong Kong, Brazil, Israel, the UAE, Jordan, Switzerland, and Iceland.

Class II in the US (FDA), Class IIb in the EU and UK (MDR / MHRA), Class B in Singapore (HSA), and Class 2 in Canada — broadly equivalent across major jurisdictions for software as a medical device with diagnostic support functionality.

Yes. Us2.ai is HIPAA-compliant (BAA available) for US deployments, GDPR-compliant (DPA available) for EU/UK, ISO 27001:2022 and SOC 2 Type II for information security, and meets the NHS Data Security and Protection Toolkit (DSPT) and DTAC requirements for UK NHS deployments. PDPA (Singapore), APP (Australia), and APPI (Japan) compliance with in-country hosting available where required. See the Deployment & Security page for the full architecture.

Cleared indications can differ between markets. For confirmation of which Us2.ai capabilities are cleared in a specific country, contact us with your market and intended clinical use.