510(k) Report

Devices descending from K210889

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

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