510(k) Report

Devices descending from K211678

5 later devices reach Lunit INSIGHT MMG through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260320Lunit INSIGHT MMG (v1.1.10)Lunit, Inc.20260—
+1K231470Lunit INSIGHT DBTLunit, Inc.20233—
+2K242652Lunit INSIGHT DBT v1.1Lunit, Inc.20242—
+3K261517qCT Lung (v1.0)Qure.Ai Technologies Pvt., Ltd.20260—
+3K253796Lunit INSIGHT DBT (V1.2)Lunit, Inc.20260—