510(k) Report

Devices descending from K042628

26 later devices reach Modification to: Radianalyzer, Model 12711 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092105Radianalyzer XpressRadi Medical Systems AB200925—
+2K252238CoroFlow Cardiovascular SystemCoroventis Research AB20250—
+2K201881CoroFlow Cardiovascular SystemCoroventis Research AB20201—
+2K190852Zurich Pressure Guidewire System Model 100Zurich Medical, Inc.20190—
+2K151613iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation201510—
+2K141615Endophys Blood Pressure MonitorEndophys, Inc.20152—
+2K123984Quantien Measurement SystemRadi Medical Systems AB20135—
+2K111854AO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb ReceiverSt. Jude Medical Systems AB20110—
+2K111201C7 XR Imaging SystemLightlab Imaging, Inc.20112—
+3K191008iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation201981
+3K172182QUANTIEN Measurement SystemSt. Jude Medical (Now Part of the Abbott Medical)20174—
+3K170204FFR Link, FFR Signal Processing ModuleBoston Scientific Corporation201701
+3K160945Endophys Blood Pressure MonitorEndophys Holdings, LLC20161—
+3K150237ILUMIEN, Drageonfly OPTIS Imaging CatheterLightlab Imaging, Inc.20151—
+4K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC20230—
+4K223812Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc.202303
+4K201178iLab Polaris Multi-Modality Guidance SystemBoston Scientific20206—
+4K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+4K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical)20193—
+5K220243Ultiri Measurement SystemAbbott Medical20220—
+5K210889iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation20214—
+5K201713AVVIGO Guidance SystemBoston Scientific Corporation20204—
+6K212490AVVIGO Guidance System IIBoston Scientific Corporation20213—
+7K230884AVVIGO'+ Multi-Modality Guidance SystemBoston Scientific Corporation2023122
+7K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+8K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific20260—