510(k) Report

Devices descending from K130243

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170948AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.201711—
+1K151613iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation201510—
+1K152403Permanent Sled BagBoston Scientific20150—
+1K152316iLab Ultrasound Imaging SystemBoston Scientific20151—
+2K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant20250—
+2K191008iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation201981
+2K190131AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20199—
+2K181577AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20190—
+2K170204FFR Link, FFR Signal Processing ModuleBoston Scientific Corporation201701
+3K223812Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc.202303
+3K201178iLab Polaris Multi-Modality Guidance SystemBoston Scientific20206—
+3K191392AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20198—
+4K210889iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation20214—
+4K201713AVVIGO Guidance SystemBoston Scientific Corporation20204—
+4K193013AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20207—
+5K212490AVVIGO Guidance System IIBoston Scientific Corporation20213—
+5K210680AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20210—
+5K201015AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20205—
+6K230884AVVIGO'+ Multi-Modality Guidance SystemBoston Scientific Corporation2023122
+6K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+6K212345AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20214—
+7K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific20260—
+7K220784AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20223—
+8K222209AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20222—
+9K231091AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20230—
+9K230606AcQMap® High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20230—