Lunit INSIGHT MMG— 510(k) K211678

Substantially Equivalent

Lunit, Inc.

FDA 510(k) clearance K211678 for Lunit INSIGHT MMG, Substantially Equivalent on 2021-11-17. Applicant: Lunit, Inc..

Clearance details

Applicant: Lunit, Inc.
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2021-06-01
Decision date: 2021-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.