Lunit Insight MMG (v1.1.10)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Lunit Inc.
Identifiers
- 510(k) Number
- K260320 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 MMG (v1.1.10) is a Radiological Computer Assisted Detection/Diagnosis Software for Lesions Suspicious for Cancer, designed to assist radiologists in identifying and evaluating mammographic findings. This software integrates advanced algorithms to enhance the detection of microcalcifications and masses, aiding in the early identification of potential breast cancer indicators during digital mammography analysis.
Supplied as a software-only solution, the Lunit Insight MMG operates on compatible radiology workstations and requires no physical hardware beyond standard imaging infrastructure. It is intended for use in radiology departments and is classified as a Class II medical device under FDA regulations, with clearance granted through a 510(k) Special Review by the Radiology Advisory Committee. The system is non-sterile, single-user, and does not interact with MRI environments, adhering to standard IT security and data protection protocols for diagnostic software.
Frequently asked questions
What is the primary purpose of the Lunit INSIGHT MMG (v1.1.10) in a clinical setting?
The Lunit INSIGHT MMG (v1.1.10) is a Radiological Computer Assisted Detection/Diagnosis Software designed to assist radiologists in analyzing digital mammograms. It uses advanced algorithms to help identify and evaluate suspicious findings—such as microcalcifications and masses—that may indicate potential breast cancer, enabling earlier detection during routine imaging.
How is the Lunit INSIGHT MMG (v1.1.10) deployed, and what hardware does it require?
The Lunit INSIGHT MMG is a software-only solution that integrates with existing radiology workstations. No additional hardware is needed beyond standard digital mammography infrastructure, as it relies on compatible IT systems for operation. It does not interact with MRI environments or require specialized equipment.
Is the Lunit INSIGHT MMG (v1.1.10) intended for single-use or repeated use, and what are its sterility and security considerations?
The software is non-sterile and designed for single-user access within radiology departments. Since it operates digitally, security and data protection follow standard IT protocols for diagnostic software, ensuring compliance with medical imaging privacy regulations without physical sterility requirements.
What regulatory pathway was followed for FDA clearance of the Lunit INSIGHT MMG (v1.1.10), and which advisory committee reviewed it?
The Lunit INSIGHT MMG received FDA clearance through a 510(k) Special Review, classified as a Class II medical device. The review was conducted by the Radiology Advisory Committee (RA), with a decision code of *SESE* (Substantially Equivalent) under the product code *QDQ*.
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 | K260320 | Class II | Active |
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Manufacturer
- Manufacturer
- Lunit Inc.
- FDA Applicant
- Lunit, Inc.
Sources (2)
- FDA 510(k) K260320 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026