Lunit INSIGHT MMG (v1.1.10)— 510(k) K260320

Substantially Equivalent

Lunit, Inc.

FDA 510(k) clearance K260320 for Lunit INSIGHT MMG (v1.1.10), Substantially Equivalent on 2026-04-23. Applicant: Lunit, Inc..

Clearance details

Applicant: Lunit, Inc.
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2026-01-30
Decision date: 2026-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Seoul, KR

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