510(k) Report

Devices descending from K131433

6 later devices reach Isys 1 (U.S),Accessory, Non-Sterile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203720MicromateIsys Medizintechnik GmbH20211—
+1K191332XACT Robotic SystemXact Robotics, Ltd.20193—
+2K230130Micromate™ Navi+Isys Medizintechnik GmbH20230—
+2K201586XACT Robotic SystemXact Robotics, Ltd.20202—
+3K213759XACT Robotic System, ACE ModelXact Robotics, Ltd.20220—
+3K221116XACT ACE Robotic SystemXact Robotics, Ltd.20220—