510(k) Report

Devices descending from K141769

22 later devices reach Optis Integrated System, Dragonfly Optis Imaging Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250751DualView CatheterTerumo Corporation20250—
+1K192019Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1Abbott Medical201910Class I
+1K151286OPTIS Integrated System Mobile WorkstationLightlab Imaging, Inc.201510—
+2K230411Dragonfly OpStar™ Imaging CatheterAbbott Medical20231—
+2K221257SpectraWAVE Imaging SystemSpectrawave, Inc.20234—
+2K210458OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemAbbott Medical20212—
+2K152120OPTIS Mobile SystemLightlab Imaging, Inc.20159—
+3K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System…Abbott Medical20260—
+3K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.20250—
+3K242098Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System…Shenzhen Vivolight Medical Device & Technology Co., Ltd.20250—
+3K243016Starlight Imaging CatheterSpectrawave, Inc.20250—
+3K230691HyperVue™ Imaging SystemSpectrawave, Inc.20231—
+3K220243Ultiri Measurement SystemAbbott Medical20220—
+3K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterGentuity, LLC20203—
+3K160878OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc.20163—
+4K251198HyperVue™ SoftwareSpectrawave, Inc.20250—
+4K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterGentuity, LLC20232—
+4K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical)20192—
+5K242239HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30…Gentuity, LLC20241—
+5K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™…Abbott Medical20230—
+5K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+6K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC202501