Lunit INSIGHT DBT v1.1— 510(k) K242652

Substantially Equivalent

Lunit, Inc.

FDA 510(k) clearance K242652 for Lunit INSIGHT DBT v1.1, Substantially Equivalent on 2024-10-04. Applicant: Lunit, Inc..

Clearance details

Applicant: Lunit, Inc.
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2024-09-04
Decision date: 2024-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Seoul, KR

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