Lunit, Inc. FDA Approvals

0 new drug approvals and 6 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Lunit INSIGHT MMG (v1.1.10)510(k)Apr 23, 2026Radiology	Radiology	510(k)Substantially Equivalent (Special)	Apr 23, 2026
Lunit INSIGHT DBT (V1.2)510(k)Mar 26, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 26, 2026
Lunit INSIGHT DBT v1.1510(k)Oct 4, 2024Radiology	Radiology	510(k)Substantially Equivalent (Special)	Oct 4, 2024
Lunit INSIGHT DBT510(k)Nov 6, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 6, 2023
Lunit INSIGHT MMG510(k)Nov 17, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 17, 2021
Lunit INSIGHT CXR Triage510(k)Nov 10, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 10, 2021