510(k) Report

Devices descending from K151613

10 later devices reach iLab Polaris Multi-Modality Guidance System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191008iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation201981
+1K170204FFR Link, FFR Signal Processing ModuleBoston Scientific Corporation201701
+2K223812Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc.202303
+2K201178iLab Polaris Multi-Modality Guidance SystemBoston Scientific20206—
+3K210889iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation20214—
+3K201713AVVIGO Guidance SystemBoston Scientific Corporation20204—
+4K212490AVVIGO Guidance System IIBoston Scientific Corporation20213—
+5K230884AVVIGO'+ Multi-Modality Guidance SystemBoston Scientific Corporation2023122
+5K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+6K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific20260—