Regulatory Status by Market
Us2.ai is cleared, approved, registered or recognized in 25 regulatory markets, and available in 9 more: Chile, and the 8 listed under Also available. The table below shows agency, status, device class, and certificate number per major market, plus the compliance frameworks relevant to hospital IT and procurement review.
Clearance and Registration by Country
Major markets are shown with their issuing agency, status, device class, and certificate number where applicable. A dash means no certificate number is published for that market; the registration document is available on request. Which capabilities each market's labeling includes is set out in What Each Edition Includes.
Americas
Europe & United Kingdom
Asia-Pacific
Middle East
Additional Markets
Us2.ai is also available for clinical use in the markets below. Contact us for the regulatory documentation set and the cleared indications that apply in your country.
- Brunei Asia-Pacific
- Georgia Europe
- Lebanon Middle East
- Qatar Middle East
- Tonga Asia-Pacific
- Tunisia Africa
- Uganda Africa
- Curaçao Americas
Cleared Products and Modules
Us2.ai ships as a base product for automated measurement and reporting, with a cardiac amyloidosis module added on top, and each carries its own clearance. Which base product is available depends on the market. Each FDA clearance below links to its record in the FDA 510(k) database.
Clearances outside the United States are listed by market above. Module availability varies by market, so contact us with your country and the modules you are considering.
Intended Use, as Labeled
Quoted word for word from the user guides. The User Guide Us2.v2, US edition, Rev M and the User Guide Us2.v2, EU edition, Rev G (11 August 2026) state the same intended use for Us2.v2. The user guide for your product edition governs; guides are published at docs.us2.ai.
Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v2 is indicated for use in adult patients.
Us2.ca processes acquired transthoracic cardiac ultrasound images to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners in their diagnosis of cardiac amyloidosis. Us2.ca is intended for use only in adult patients with increased left ventricular wall thickness, defined as an interventricular septal thickness (IVSd) or left ventricular posterior wall thickness (LVPWd) ≥ 12mm. Us2.ca is not intended to provide a diagnosis and does not replace current standards of care. The results from Us2.ca are not intended to exclude the need for further follow-up on cardiac amyloidosis.
Heart failure category, aortic stenosis grade and pulmonary hypertension probability appear in the report as conclusions the software draws from its measurements using international guidelines, for the clinician to review before sign-off. They are not separate diagnostic indications. Cardiac amyloidosis is the one disease-specific module with its own FDA clearance (K250151).
What Each Edition Includes
Which capabilities appear in the labeling of each product edition, and the markets that receive it. Labeling reviewed 2026-11-04.
The cardiac amyloidosis module is not part of the labeled product in Japan, Malaysia and India. For the capabilities labeled in any market not named here, contact us with your country.
Privacy, Security & Quality Frameworks
The certifications and frameworks Us2.ai operates under, common to hospital IT and procurement review.
Common Regulatory Questions
If your question isn't covered, contact us with the country and intended clinical use.
Is Us2.ai FDA cleared?
Yes. FDA cleared Us2.v1 in 2021 under K210791 and Us2.v2 in 2024 under K233676, each as a Class II device under 21 CFR 892.2050. FDA cleared the Us2.ca cardiac amyloidosis module separately in 2025 under K250151, as a Class II device under 21 CFR 870.2200.
Is Us2.ai CE marked?
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.
In how many markets is Us2.ai approved?
Us2.ai is available in 34 regulatory markets: cleared, approved, registered or recognized in 25 of them, and available in the other 9. They include 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, Saudi Arabia, Jordan, Lebanon, Tunisia, Uganda and Curaçao.
Which device class is Us2.ai?
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.
Does Us2.ai meet hospital IT and data-residency requirements?
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.
What does "Available" mean in the market table?
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.
Where do specific cleared indications apply?
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.
Regulatory clearance is local. So is the conversation.
Confirm Indications for Your Market
Cleared clinical indications can differ between countries. Contact our team with your market and intended clinical use, and we'll confirm the specifics and share the relevant regulatory documentation.