510(k) Report

Devices descending from K191008

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

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