510(k) Report

Devices descending from K192019

10 later devices reach Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230411Dragonfly OpStar™ Imaging CatheterAbbott Medical20231—
+1K221257SpectraWAVE Imaging SystemSpectrawave, Inc.20234—
+1K210458OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemAbbott Medical20212—
+2K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System…Abbott Medical20260—
+2K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.20250—
+2K242098Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System…Shenzhen Vivolight Medical Device & Technology Co., Ltd.20250—
+2K243016Starlight Imaging CatheterSpectrawave, Inc.20250—
+2K230691HyperVue™ Imaging SystemSpectrawave, Inc.20231—
+2K220243Ultiri Measurement SystemAbbott Medical20220—
+3K251198HyperVue™ SoftwareSpectrawave, Inc.20250—