510(k) Report

Devices descending from K200511

5 later devices reach ROSA ONE Brain application through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241333Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20251—
+1K220072Sinobot X1Sinovation (Beijing) Medical Technology Co., Ltd.20230—
+1K214065ROSA ONE Brain applicationMedtech S.A.S20221—
+2K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.20260—
+2K231103ROSA ONE Brain ApplicationMedtech S.A.S20230—