510(k) Report

Devices descending from K112997

4 later devices reach HD-Ivus Ultrasound Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122878HD-Ivus Ultrasound Imaging SystemSilicon Vally Medical Instruments, Inc.20133—
+2K173063ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc.20172—
+3K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc.20191—
+4K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc.20200Class I