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, registered or available in 28+ regulatory markets worldwide, including the United States, European Union, United Kingdom, Switzerland, Iceland, Georgia, Canada, Brazil, Argentina, Chile, Australia, New Zealand, Japan, Singapore, India, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Taiwan, Hong Kong, Brunei, Tonga, Israel, the United Arab Emirates, Qatar, Jordan, Lebanon, Tunisia and Uganda.

Class II in the United States (FDA), Class IIb in the European Union and United Kingdom (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 United States deployments, GDPR-compliant (DPA available) for the European Union and United Kingdom, 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.

Market authorization takes several forms: a national registration certificate, recognition of the CE mark, or a route particular to that country. "Available" means Us2.ai may be supplied and used clinically in that market. Us2.ai is FDA 510(k) cleared and CE marked as a Class IIb medical device across every market on this page. Contact us with your country and intended clinical use and we will send the documentation set that applies there.

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.