End User License Agreement

FDA Clearance:

Falcon MD™ is FDA-cleared under two distinct 510(k) submissions:

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macOS Configuration

• 510(k) No. K232589 (cleared as Horos MD™) under 21 CFR 892.2050, Class II (product code LLZ).

• Clearance applies exclusively when used on a Mac computer with an FDA-approved monitor, as specified in the Instructions for Use. This clearance is conditional and should not be construed as an endorsement of Falcon MD™’s safety or effectiveness in any other configuration.

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iOS & iPadOS Configuration

• 510(k) No. K242552 (cleared as Horos Mobile™) under 21 CFR 892.2050, Class II (product code LLZ).

• Cleared for use on iPhone and iPad devices only; not intended to replace a full diagnostic workstation  - use only when a workstation is not accessible.

 

The medical device identified by 510(k) No. K232589 as Horos MD™ will be commercially known and marketed as Falcon MD™.

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The medical device identified by 510(k) No. K242552 as Horos Mobile™ will be commercially known and marketed as Falcon MD™.

 

Non-Clearance Notification:

Falcon Mx™ (for iPhone, iPad, and Mac) and Falcon Vue™ are not FDA-cleared and have not received CE marking. Users must consult local regulatory authorities for guidance on using non-cleared software in their jurisdiction.

 

END USER LICENSE AGREEMENT

 

iCat Solutions Ltd (“Application Provider”) provides the application (“Licensed Application”) and related online features (“Services”) to you (“You” or “Your”) under this End User License Agreement (“Agreement”). By installing or using the Licensed Application or the Services, You agree to be bound by this Agreement. If You do not agree, do not use the Licensed Application or Services.

 

a. Scope of License.

Application Provider grants You a non-exclusive, non-transferable license to install and use the Licensed Application on any iPhone, iPod Touch, iPad, or Mac computer You own or control, and to access the Services, as permitted by the App Store Usage Rules and this Agreement. You may not distribute, sublicense, rent, lease, lend, sell, or otherwise make the Licensed Application available over a network for multiple users. You may not reverse-engineer, decompile, disassemble, or attempt to derive source code, except as expressly permitted by law. Any upgrades provided by Application Provider are governed by this Agreement unless accompanied by a separate license.

 

b. Consent to Use of Data.

You agree that Application Provider may collect and use technical data and related information—such as device, system, and application software data—to facilitate updates, support, and other Services. Subject to applicable law, Application Provider may share anonymized or aggregated data with third parties to improve products and services.

 

c. Termination.

This license is effective until terminated. Your rights under this Agreement terminate automatically without notice if You fail to comply with any term. Upon termination, You must cease use of the Licensed Application and delete all copies.

 

d. Third-Party Materials.

The Licensed Application may surface third-party content or links (“Third-Party Materials”). You use all Third-Party Materials at Your own risk. Application Provider disclaims any liability for Third-Party Materials’ accuracy, legality, decency, or quality. You agree not to infringe any third-party rights or violate any laws through your use of the Services.

 

e. No Representations or Warranties.

TO THE FULLEST EXTENT PERMITTED BY LAW, THE LICENSED APPLICATION AND SERVICES ARE PROVIDED “AS IS” AND “AS AVAILABLE,” WITHOUT ANY WARRANTY WHATSOEVER. APPLICATION PROVIDER DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT. SOME JURISDICTIONS DO NOT ALLOW EXCLUSION OF IMPLIED WARRANTIES, SO THIS EXCLUSION MAY NOT APPLY TO YOU.

 

f. Use of Licensed Application and Services.

You agree that the Licensed Application and Services are designed to be used only under the supervision of qualified healthcare professionals and as part of a prescribed treatment plan. They do not constitute medical advice and are not substitutes for professional judgment.

 

g. Indemnification.

You agree to indemnify and hold harmless Application Provider and its affiliates from any claims, liabilities, damages, or expenses (including attorneys’ fees) arising out of (i) your use of the Licensed Application or Services; (ii) any breach of this Agreement by you; or (iii) infringement by you of any third-party rights.

 

h. Limitation of Liability.

IN NO EVENT WILL APPLICATION PROVIDER BE LIABLE FOR ANY SPECIAL, INCIDENTAL, INDIRECT, OR CONSEQUENTIAL DAMAGES, INCLUDING LOST PROFITS OR DATA, ARISING OUT OF OR RELATED TO YOUR USE OR INABILITY TO USE THE LICENSED APPLICATION OR SERVICES. WHERE NOT PROHIBITED BY LAW, APPLICATION PROVIDER’S TOTAL LIABILITY WILL NOT EXCEED US $200.

 

i. Intellectual Property.

The Licensed Application and all associated intellectual property rights remain the exclusive property of Application Provider and its licensors.

 

j. Export Control.

You may not export or re-export the Licensed Application except in compliance with U.S. and local export laws. By using the Licensed Application, you represent that you are not located in any embargoed country or on any U.S. restricted-party list.

 

k. U.S. Government End Users.

The Licensed Application and documentation are Commercial Items, as defined in 48 C.F.R. §§2.101, 12.212, and 227.7202.

 

l. No Waiver.

Failure to enforce any provision of this Agreement does not waive future enforcement of that or any other provision.

 

m. Severability.

If any provision is held unenforceable, the remaining provisions remain in full force and effect.

 

n. Changes to Agreement.

Application Provider may revise this Agreement at any time by posting the updated version in the App Store listing. Continued use after posting constitutes acceptance of the new terms.

 

o. Governing Law.

This Agreement is governed by the laws of the State of California, excluding its conflict-of-law rules.

 

p. Dispute Resolution.

Any dispute arising under this Agreement must be filed within one year of its accrual and resolved exclusively in the state or federal courts located in San Diego County, California. YOU AND APPLICATION PROVIDER WAIVE ANY RIGHT TO A JURY TRIAL OR CLASS-ACTION RELIEF, TO THE EXTENT PERMITTED BY LAW.

 

q. Entire Agreement.

This Agreement constitutes the entire understanding between You and Application Provider regarding the Licensed Application and Services and supersedes all prior agreements.

 

Last revision: April 25, 2025