510(k) Report

Devices descending from K123369

28 later devices reach Ilumien Optis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141453Ilumien Optis, Dragonfly Optis Imaging CatheterLightlab Imaging, Inc.201414—
+1K141769Optis Integrated System, Dragonfly Optis Imaging CatheterLightlab Imaging, Inc.201422—
+2K250751DualView CatheterTerumo Corporation20250—
+2K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant20250—
+2K242098Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System…Shenzhen Vivolight Medical Device & Technology Co., Ltd.20250—
+2K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterGentuity, LLC20203—
+2K192019Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1Abbott Medical201910Class I
+2K172258Novasight Hybrid SystemConavi Medical, Inc.20181Class I
+2K151286OPTIS Integrated System Mobile WorkstationLightlab Imaging, Inc.201510—
+2K150878Ilumien OptisLightlab Imaging, Inc.201510—
+3K252945Novasight Hybrid SystemConavi Medical, Inc.20260—
+3K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterGentuity, LLC20232—
+3K230411Dragonfly OpStar™ Imaging CatheterAbbott Medical20231—
+3K221257SpectraWAVE Imaging SystemSpectrawave, Inc.20234—
+3K210458OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemAbbott Medical20212—
+3K152120OPTIS Mobile SystemLightlab Imaging, Inc.20159—
+4K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System…Abbott Medical20260—
+4K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.20250—
+4K243016Starlight Imaging CatheterSpectrawave, Inc.20250—
+4K242239HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30…Gentuity, LLC20241—
+4K230691HyperVue™ Imaging SystemSpectrawave, Inc.20231—
+4K220243Ultiri Measurement SystemAbbott Medical20220—
+4K160878OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc.20163—
+5K251198HyperVue™ SoftwareSpectrawave, Inc.20250—
+5K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC202501
+5K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical)20192—
+6K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™…Abbott Medical20230—
+6K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—