510(k) Report

Devices descending from K870513

2 later devices reach CSI/3D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131528Non-Pyrogenic Ultrasound Transducer CoverCIVCO Medical Instruments Co., Inc.20131—
+2K222460Intraoperative Ultrasound Probe CoverExact Medical Manufacturing20230—