510(k) Report

Devices descending from K201178

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210889iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation20214—
+1K201713AVVIGO Guidance SystemBoston Scientific Corporation20204—
+2K212490AVVIGO Guidance System IIBoston Scientific Corporation20213—
+3K230884AVVIGO'+ Multi-Modality Guidance SystemBoston Scientific Corporation2023122
+3K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+4K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific20260—