510(k) Report

Devices descending from K072517

28 later devices reach Ilab Ultrasound Imaging System, Version 1.3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123535Ilab Ultrasound Imaging SystemBoston Scientific Corp201327—
+2K130243Ilab Ultrasound Imaging SystemBoston Scientific Corp201326—
+3K170948AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.201711—
+3K151613iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation201510—
+3K152403Permanent Sled BagBoston Scientific20150—
+3K152316iLab Ultrasound Imaging SystemBoston Scientific20151—
+4K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant20250—
+4K191008iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation201981
+4K190131AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20199—
+4K181577AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20190—
+4K170204FFR Link, FFR Signal Processing ModuleBoston Scientific Corporation201701
+5K223812Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc.202303
+5K201178iLab Polaris Multi-Modality Guidance SystemBoston Scientific20206—
+5K191392AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20198—
+6K210889iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation20214—
+6K201713AVVIGO Guidance SystemBoston Scientific Corporation20204—
+6K193013AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20207—
+7K212490AVVIGO Guidance System IIBoston Scientific Corporation20213—
+7K210680AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20210—
+7K201015AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20205—
+8K230884AVVIGO'+ Multi-Modality Guidance SystemBoston Scientific Corporation2023122
+8K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+8K212345AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20214—
+9K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific20260—
+9K220784AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20223—
+10K222209AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20222—
+11K231091AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20230—
+11K230606AcQMap® High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20230—