510(k) Report

Devices descending from K133323

18 later devices reach Volcano Ifr Modality through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical)20192—
+1K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical)20193—
+1K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…Volcano Corporation20184—
+1K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izVolcano Corporation20152—
+1K150441Volcano iFR Modality, iFR Scout featureVolcano Corporation20159—
+1K143122Volcano iFR Harvest Software (Offline)Volcano Corporation20150—
+2K252238CoroFlow Cardiovascular SystemCoroventis Research AB20250—
+2K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+2K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™…Abbott Medical20230—
+2K220243Ultiri Measurement SystemAbbott Medical20220—
+2K201881CoroFlow Cardiovascular SystemCoroventis Research AB20201—
+2K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+2K190078IntraSightVolcano Corporation20192—
+2K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…Volcano Corporation201701
+2K170133FFR V2.5Philips Volcano201751
+2K170385CORE M2 Vascular SystemVolcano Corporation20171—
+3K253714IntraSight PlusPhilips Image Guided Therapy Corporation202601
+3K203719IntraSight MobileVolcano Corporation202101