Lunit INSIGHT DBT v1.1
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Lunit Inc.
Identifiers
- 510(k) Number
- K242652 FDA 510(k)
- FDA Product Code
- QDQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2090 FDA 510(k)
- Regulation Number
- 892.2090 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lunit INSIGHT DBT v1.1 is a Radiological Computer Assisted Detection/Diagnosis Software for Lesions Suspicious for Cancer, designed to assist radiologists in identifying potential abnormalities in digital breast tomosynthesis (DBT) imaging. It employs advanced algorithms to enhance lesion detection and characterization, supporting early and accurate diagnosis of suspicious findings in breast tissue.
This software is supplied as a digital solution, intended for use in radiology departments equipped with compatible DBT systems. It operates as a Class II medical device under FDA 510(k) clearance (Special Review, Substantially Equivalent) and MDR compliance, with no indication of single-use or sterility requirements. The system is non-invasive and does not interact with MRI or other imaging modalities, requiring no specialized storage beyond standard IT infrastructure for software deployment.
Frequently asked questions
What types of imaging systems is the Lunit INSIGHT DBT v1.1 designed to work with, and how is it deployed in a clinical setting?
The Lunit INSIGHT DBT v1.1 is specifically designed to assist with digital breast tomosynthesis (DBT) imaging only. It is supplied as a digital software solution and requires integration with compatible DBT systems already installed in radiology departments. Since it is non-invasive and does not interact with other imaging modalities like MRI, deployment only requires standard IT infrastructure for software installation and operation, ensuring seamless integration into existing workflows.
Is the Lunit INSIGHT DBT v1.1 intended for single-use or repeated use in clinical practice, and does it require sterilization?
The Lunit INSIGHT DBT v1.1 is a software-based medical device, meaning it is designed for repeated use within radiology departments. Unlike physical devices, it does not require sterilization or single-use disposal, as it operates digitally without direct patient contact or physical degradation over time.
What regulatory pathways has the Lunit INSIGHT DBT v1.1 followed, and which governing bodies have approved its use?
The Lunit INSIGHT DBT v1.1 has undergone FDA 510(k) clearance under a Special Review process, with a determination of Substantially Equivalent to a predicate device. It also complies with EU Medical Device Regulation (MDR) standards. These pathways confirm its classification as a Class II medical device, ensuring it meets stringent safety and performance requirements for assisting radiologists in breast lesion detection.
How does the Lunit INSIGHT DBT v1.1 assist radiologists in their diagnostic workflow, and what specific features does it provide?
The Lunit INSIGHT DBT v1.1 employs advanced algorithms to enhance lesion detection and characterization in digital breast tomosynthesis (DBT) images. It is designed to assist radiologists by highlighting potential abnormalities suspicious for cancer, supporting early and accurate diagnosis of breast tissue findings. While it does not replace clinical judgment, it serves as a computer-aided detection/diagnosis tool to improve diagnostic confidence and efficiency.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K242652 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lunit Inc.
- FDA Applicant
- Lunit, Inc.
Sources (2)
- FDA 510(k) K242652 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026