K211733

Substantially Equivalent

Lunit INSIGHT CXR Triage

Applicant: Lunit, Inc.
Product code: QFM
Advisory panel: Radiology
Date received: 2021-06-04
Decision date: 2021-11-10
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.