510(k) Report

Devices descending from K152120

9 later devices reach OPTIS Mobile System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242098Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System…Shenzhen Vivolight Medical Device & Technology Co., Ltd.20250—
+1K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterGentuity, LLC20203—
+1K160878OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc.20163—
+2K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterGentuity, LLC20232—
+2K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical)20192—
+3K242239HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30…Gentuity, LLC20241—
+3K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™…Abbott Medical20230—
+3K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+4K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC202501