510(k) Report

Devices descending from K051679

36 later devices reach Ilab Ultrasound Imaging System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122878HD-Ivus Ultrasound Imaging SystemSilicon Vally Medical Instruments, Inc.20133—
+1K112997HD-Ivus Ultrasound Imaging SystemSilicon Vally Medical Instruments, Inc.20114—
+1K093993Lipiscan Ivus Imaging System Model Nirs-MC7-70Infraredx, Inc.20100—
+1K072517Ilab Ultrasound Imaging System, Version 1.3Boston Scientific Corp2007281
+1K063493I Review Software (Accessory to) Ilab Ultrasound Imaging System) VERSION1.0Boston Scientific Corp200601
+2K173063ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc.20172—
+2K123535Ilab Ultrasound Imaging SystemBoston Scientific Corp201327—
+3K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc.20191—
+3K130243Ilab Ultrasound Imaging SystemBoston Scientific Corp201326—
+4K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc.20200Class I
+4K170948AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.201711—
+4K151613iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation201510—
+4K152403Permanent Sled BagBoston Scientific20150—
+4K152316iLab Ultrasound Imaging SystemBoston Scientific20151—
+5K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant20250—
+5K191008iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation201981
+5K190131AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20199—
+5K181577AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20190—
+5K170204FFR Link, FFR Signal Processing ModuleBoston Scientific Corporation201701
+6K223812Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc.202303
+6K201178iLab Polaris Multi-Modality Guidance SystemBoston Scientific20206—
+6K191392AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20198—
+7K210889iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation20214—
+7K201713AVVIGO Guidance SystemBoston Scientific Corporation20204—
+7K193013AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20207—
+8K212490AVVIGO Guidance System IIBoston Scientific Corporation20213—
+8K210680AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20210—
+8K201015AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20205—
+9K230884AVVIGO'+ Multi-Modality Guidance SystemBoston Scientific Corporation2023122
+9K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+9K212345AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20214—
+10K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific20260—
+10K220784AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20223—
+11K222209AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20222—
+12K231091AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20230—
+12K230606AcQMap® High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20230—