510(k) Report

Devices descending from K162474

3 later devices reach Artemis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222222Artemis, Artemis TPO, Artemis MXEigen20230—
+1K221499Minimally Invasive Prostate Surgery Navigation SystemAugment Intelligent Medical System (China) Co., Ltd.20221—
+2K242314Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-2)Augment Intelligent Medical System (China) Co., Ltd.20250—