Lunit US Product Disclaimers

1. Lunit International Disclaimer 

Copyright © Lunit International Limited 2026. All rights reserved.

Third-party trademarks are the property of their respective owners.

The following products are Lunit International Limited’s (“Lunit International”) flagship products: Analytics™, Volpara® Scorecard™, Volpara® Live™, Patient Hub™, Risk Pathways™.

Volpara® Scorecard™ is CE-marked in compliance with the EU Medical Devices Directive (MDD) 93/42/EEC and applicable EU standards. 

Volpara® Scorecard™ is FDA-cleared, while Volpara® Live™ is FDA registered. 

Risk Pathways™ is intended to provide clinical decision support (CDS) in the US. Please note that it is not a CE-marked device. 

Please note that Analytics™ and Patient Hub™ are not classified as medical devices. 

The Lunit International devices are adjunctive tools, not diagnostic aids, and are intended for use by healthcare professionals who should ultimately rely on their own assessment for a final decision. 

This document is for use by healthcare professionals only. The radiologist should always rely on his or her own clinical and professional opinion when deciding whether to use a certain product to diagnose or treat a patient.

Availability of Lunit International products may vary by market, depending on local medical and/or regulatory requirements. Please contact your Lunit International representative if you have questions about the availability of the Lunit International products in your area.

Lunit International Limited, Level 4, 1 Victoria Street Wellington Central, Wellington, 6011 New Zealand

2. Lunit INSIGHT® MMG Disclaimer

The product described is CE-marked and complies with the EU Medical Device Regulation (MDR) 2017/745 and applicable EU standards. It is also FDA-cleared, with the exception of certain features. Please contact your local Lunit representative for more details. 

Lunit INSIGHT® MMG is a Computer-Assisted Detection/Diagnosis (CADe/x) software intended to aid in the detection, localization, and characterization of suspicious breast cancer in mammograms. The device is an adjunctive tool, supporting readings for interpreting physicians and should be used only after the first reading by interpreting physicians.

This document is for use by healthcare professionals only. The radiologist should always rely on his or her own clinical and professional opinion when deciding whether to use a certain product to diagnose or treat a patient.

Availability of Lunit products may vary by market, depending on local medical and/or regulatory requirements. Please contact your Lunit representative if you have questions about the availability of the Lunit products in your area.

Lunit Inc. owns, uses or enforces the following trademarks or service marks: Lunit, Lunit.

Lunit Inc., 4-8 F, 374, Gangnam-daero, Gangnam-gu, Seoul, 06241, Republic of Korea

3. Lunit INSIGHT® DBT Disclaimer

The product described is CE-marked and complies with the EU Medical Device Regulation (MDR) 2017/745 and applicable EU standards. It is also FDA-cleared. 

Lunit INSIGHT® DBT is a Computer-Assisted Detection/Diagnosis (CADe/x) software intended to be used concurrently by interpreting physicians to aid in the detection and characterization of suspicious lesions for breast cancer in digital breast tomosynthesis (DBT) exams. The device is an adjunctive tool, supporting readings for interpreting physicians. 

This document is for use by healthcare professionals only. The radiologist should always rely on his or her own clinical and professional opinion when deciding whether to use a certain product to diagnose or treat a patient.

Availability of Lunit products may vary by market, depending on local medical and/or regulatory requirements. Please contact your Lunit representative if you have questions about the availability of the Lunit products in your area.

Lunit Inc. owns, uses or enforces the following trademarks or service marks: Lunit, Lunit INSIGHT.

Lunit Inc., 4-8 F, 374, Gangnam-daero, Gangnam-gu, Seoul, 06241, Republic of Korea

4. Lunit INSIGHT® Breast Suite Disclaimer

Lunit INSIGHT® Breast Suite refers to two of Lunit Inc.'s flagship products, Lunit INSIGHT® MMG and Lunit INSIGHT® DBT.

Both products are CE-marked and comply with the EU Medical Device Regulation (MDR) 2017/745 and applicable EU standards. They are also FDA-cleared, with the exception of certain features of Lunit INSIGHT® MMG. 

Lunit INSIGHT® MMG may not include certain features in the US. Please contact your local Lunit representative for more details. 

Lunit INSIGHT® MMG is a Computer-Assisted Detection/Diagnosis (CADe/x) software intended to aid in the detection, localization, and characterization of suspicious breast cancer in mammograms. 

Lunit INSIGHT® DBT is a Computer-Assisted Detection/Diagnosis (CADe/x) software intended to be used concurrently by interpreting physicians to aid in the detection and characterization of suspicious lesions for breast cancer in digital breast tomosynthesis (DBT) exams. 

The devices are adjunctive tools, supporting readings for interpreting physicians. Lunit INSIGHT® MMG should be used only after the first reading by interpreting physicians.

This document is for use by healthcare professionals only. The radiologist should always rely on his or her own clinical and professional opinion when deciding whether to use a certain product to diagnose or treat a patient.

Availability of Lunit products may vary by market, depending on local medical and/or regulatory requirements. Please contact your Lunit representative if you have questions about the availability of the Lunit products in your area.

Lunit Inc. owns, uses or enforces the following trademarks or service marks: Lunit, Lunit INSIGHT.

Lunit Inc., 4-8 F, 374, Gangnam-daero, Gangnam-gu, Seoul, 06241, Republic of Korea

5. Lunit INSIGHT® Breast Suite x Lunit International Disclaimer

The products described are Lunit Inc. (“Lunit”) and Lunit International Limited’s (“Lunit International”) flagship products.

•    Lunit: Lunit INSIGHT® MMG, Lunit INSIGHT® DBT
•    Lunit International: Analytics™, Volpara® Scorecard™, Volpara® Live™, Patient Hub™, Risk Pathways™

All Lunit’s products are CE-marked and comply with the EU Medical Device Regulation (MDR) 2017/745 and applicable EU standards. 

Lunit INSIGHT® MMG and Lunit INSIGHT® DBT are FDA-cleared, with the exception of certain features of Lunit INSIGHT® MMG.

Lunit INSIGHT® MMG may not include certain features in the US. Please contact your local Lunit representative for more details. 

The Lunit devices are adjunctive tools, supporting readings for interpreting physicians.

Lunit INSIGHT® MMG should be used only after the first reading by interpreting physicians.

Volpara® Scorecard™ is CE-marked in compliance with the EU Medical Devices Directive (MDD) 93/42/EEC and applicable EU standards. 

Volpara® Scorecard™ is FDA-cleared, while Volpara® Live™ is FDA registered. 

Risk Pathways™ is intended to provide clinical decision support (CDS) in the US. Please note that it is not a CE-marked device. 

Please note that Analytics™ and Patient Hub™ are not classified as medical devices. 

The Lunit International devices are adjunctive tools, not diagnostic aids, and are intended for use by healthcare professionals who should ultimately rely on their own assessment for a final decision. 

This document is for use by healthcare professionals only. The radiologist should always rely on his or her own clinical and professional opinion when deciding whether to use a certain product to diagnose or treat a patient.

Availability of Lunit products may vary by market, depending on local medical and/or regulatory requirements. Please contact your Lunit or Lunit International representative if you have questions about the availability of the Lunit and Lunit International products in your area.

Lunit Inc. owns, uses or enforces the following trademarks or service marks: Lunit, Lunit INSIGHT.

Lunit Inc., 4-8 F, 374, Gangnam-daero, Gangnam-gu, Seoul, 06241, Republic of Korea

Lunit International Limited, Level 4, 1 Victoria Street Wellington Central, Wellington, 6011 New Zealand