Lunit INSIGHT MMG (v1.1.10)— 510(k) K260320
Substantially EquivalentLunit, Inc.
FDA 510(k) clearance K260320 for Lunit INSIGHT MMG (v1.1.10), Substantially Equivalent on 2026-04-23. Applicant: Lunit, Inc.. Device class: 2.
Summary
Lunit's Lunit INSIGHT MMG (v1.1.10) is filed under product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer). The name carries a version designation, v1.1.10.
Class II, 21 CFR 892.2090. Radiology is both the classification panel and the review panel. It came in as a Special 510(k).
Lunit filed from Seoul, South Korea. The record shows 83 calendar days from receipt to decision (January 30 to April 23, 2026).
Clearance details
- Applicant
- Lunit, Inc.
- Product code
- Product code QDQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Seoul, KR
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