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Lunit US Product Disclaimers
1. 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
2. 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
3. Lunit INSIGHT Breast Suite disclaimer
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.
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
4. Lunit INSIGHT x Volpara disclaimer
- Lunit: Lunit INSIGHT MMG, Lunit INSIGHT DBT
- Volpara: Analytics, Scorecard, 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.
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.
Scorecard and Live are CE-marked in compliance with the EU Medical Devices Directive (MDD) 93/42/EEC and applicable EU standards.
Scorecard is FDA cleared, while 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 Volpara 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 Volpara representative if you have questions about the availability of the Lunit and Volpara 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
Volpara Health Technologies Limited, Level 4, 1 Victoria Street Wellington Central, Wellington, 6011 New Zealand