510(k) Report

Devices descending from K231470

3 later devices reach Lunit INSIGHT DBT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242652Lunit INSIGHT DBT v1.1Lunit, Inc.20242—
+2K261517qCT Lung (v1.0)Qure.Ai Technologies Pvt., Ltd.20260—
+2K253796Lunit INSIGHT DBT (V1.2)Lunit, Inc.20260—