510(k) Report

Devices descending from K042188

48 later devices reach Volcano Therapeutics, Inc. Volcano Ivus System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072932Infraredix Nir Imaging System, Gen. 1.0, Model MC-5Infraredx, Inc.20081—
+1K051337Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus System, Model…Volcano Corporation200547—
+2K093993Lipiscan Ivus Imaging System Model Nirs-MC7-70Infraredx, Inc.20100—
+2K091780Guided Measurement Catheter (GMC)Mediguide, Ltd.20091—
+2K073473Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging Catheter…Volcano Corporation200814—
+2K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation2008282
+3K172258Novasight Hybrid SystemConavi Medical, Inc.20181Class I
+3K142235CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner CatheterSt Jude Medical20140—
+3K092596Eagle Eye Platinum Digital Ivus CatheterVolcano Corporation200913—
+3K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation2008253
+4K252945Novasight Hybrid SystemConavi Medical, Inc.20260—
+4K143701Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014…Volcano Corporation201510—
+4K120697Eagle Eye Platinum ST CatheterVolcano Corporation201212—
+4K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation2011241
+5K232584Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle…Vein 360, LLC20230—
+5K210655Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterInnovative Health, LLC20221—
+5K200410Reconnaissance PV .018 OTW Digital IVUS CatheterPhilips Image Guided Therapy Corporation20201—
+5K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc.20191—
+5K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation201602
+5K152829Visions PV.014P RX Digital IVUS CatheterVolcano Corporation201541
+5K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation20132110
+5K113486Volcano S5I Intravascular Ultracound Imaging and Pressure SystemVolcano Corporation20122—
+6K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device20250—
+6K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+6K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNortheast Scientific, Inc.20230—
+6K200195NES Reprocessed Visions PV .014P RX Digital IVUS CatheterNortheast Scientific, Inc.20201—
+6K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc.20200Class I
+6K133323Volcano Ifr ModalityVolcano Corporation201418—
+6K133142Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for…Volcano Corporation20130—
+6K132659Volcano Preview Forward-Looking Ivus SystemVolcano Corporation20130—
+6K122826Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000…Volcano Corporation20131—
+7K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical)20192—
+7K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical)20193—
+7K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…Volcano Corporation20184—
+7K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izVolcano Corporation20152—
+7K150441Volcano iFR Modality, iFR Scout featureVolcano Corporation20159—
+7K143122Volcano iFR Harvest Software (Offline)Volcano Corporation20150—
+8K252238CoroFlow Cardiovascular SystemCoroventis Research AB20250—
+8K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™…Abbott Medical20230—
+8K220243Ultiri Measurement SystemAbbott Medical20220—
+8K201881CoroFlow Cardiovascular SystemCoroventis Research AB20201—
+8K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+8K190078IntraSightVolcano Corporation20192—
+8K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…Volcano Corporation201701
+8K170133FFR V2.5Philips Volcano201751
+8K170385CORE M2 Vascular SystemVolcano Corporation20171—
+9K253714IntraSight PlusPhilips Image Guided Therapy Corporation202601
+9K203719IntraSight MobileVolcano Corporation202101