510(k) Report

Devices descending from K041637

8 later devices reach Targetscan Transrectal Ultrasound System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163502iSR'obot Biopsy KitBiobot Surgical Pte., Ltd.20172—
+1K111347Isrobot Mona LisaBiobot Surgical Pte., Ltd.20114—
+1K073399Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideEnvisioneering, LLC20071—
+2K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+2K130944Isr'obot Mona LisaBiobot Surgical Pte., Ltd.20133—
+2K081323Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818B-K Medical Aps20080—
+3K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+3K203659iSR'obot Mona Lisa 1.0Biobot Surgical Pte., Ltd.20212—