510(k) Report

Devices descending from K933517

89 later devices reach Automatic Pull Back Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024103Ivus PlusIndec Systems, Inc.20030—
+1K974457Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ Coronary Imaging Catheter…Hewlett-Packard Co.199832—
+1K980851Galaxy Intravascular Ultrasound System, Model I5028Boston Scientific Corp199883—
+1K971397Viewcath 3-D Catheter PullbackQuinton, Inc.19970—
+2K151126Foresight Intracardiac Echocardiography (ICE) SystemColibri Technologies, Inc.20151—
+2K121913Reprocessed Ultrasound Intracardiac Echo CatheterStryker Sustainability Solutions, Inc.20120—
+2K093857C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable AccessoriesLightlab Imaging, Inc.201011—
+2K072932Infraredix Nir Imaging System, Gen. 1.0, Model MC-5Infraredx, Inc.20081—
+2K052348IN Vision Gold with Spin Vision, Model 891 SVVolcano Corporation200529—
+2K051679Ilab Ultrasound Imaging SystemBoston Scientific Corp2005362
+2K050995Revolution 45 MHZ Rotational Ivus Imaging CatheterVolcano Corporation200531—
+3K172258Novasight Hybrid SystemConavi Medical, Inc.20181Class I
+3K162789Foresight Intracardiac Echocardiology (ICE) SystemConavi Medical, Inc.20170—
+3K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsoleAvinger, Inc.20147—
+3K122878HD-Ivus Ultrasound Imaging SystemSilicon Vally Medical Instruments, Inc.20133—
+3K112997HD-Ivus Ultrasound Imaging SystemSilicon Vally Medical Instruments, Inc.20114—
+3K111201C7 XR Imaging SystemLightlab Imaging, Inc.20112—
+3K093993Lipiscan Ivus Imaging System Model Nirs-MC7-70Infraredx, Inc.20100—
+3K080891Revolution 45MHZ Ivus Imaging CatheterVolcano Corporation20083—
+3K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation2008282
+3K072517Ilab Ultrasound Imaging System, Version 1.3Boston Scientific Corp2007281
+3K063493I Review Software (Accessory to) Ilab Ultrasound Imaging System) VERSION1.0Boston Scientific Corp200601
+4K252945Novasight Hybrid SystemConavi Medical, Inc.20260—
+4K173063ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc.20172—
+4K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation201602
+4K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc.20163—
+4K152275Pantheris SystemAvinger, Inc.20156—
+4K150237ILUMIEN, Drageonfly OPTIS Imaging CatheterLightlab Imaging, Inc.20151—
+4K122826Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000…Volcano Corporation20131—
+4K123535Ilab Ultrasound Imaging SystemBoston Scientific Corp201327—
+4K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation2008253
+5K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+5K191175ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc.20191—
+5K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…Avinger, Inc.20172—
+5K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.20165—
+5K132659Volcano Preview Forward-Looking Ivus SystemVolcano Corporation20130—
+5K130243Ilab Ultrasound Imaging SystemBoston Scientific Corp201326—
+5K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation2011241
+6K193183ACIST HDi System, ACIST Kodama Intravascular Ultrasound CatheterAcist Medical Systems, Inc.20200Class I
+6K173862Pantheris SystemAvinger, Inc.20181—
+6K170948AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.201711—
+6K160827Pantheris CatheterAvinger, Inc.20164—
+6K151613iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation201510—
+6K152403Permanent Sled BagBoston Scientific20150—
+6K152316iLab Ultrasound Imaging SystemBoston Scientific20151—
+6K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation20132110
+6K113486Volcano S5I Intravascular Ultracound Imaging and Pressure SystemVolcano Corporation20122—
+7K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant20250—
+7K212047Pantheris SystemAvinger, Inc.20210—
+7K191008iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation201981
+7K190131AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20199—
+7K181577AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20190—
+7K170204FFR Link, FFR Signal Processing ModuleBoston Scientific Corporation201701
+7K133323Volcano Ifr ModalityVolcano Corporation201418—
+7K133142Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for…Volcano Corporation20130—
+8K223812Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc.202303
+8K201178iLab Polaris Multi-Modality Guidance SystemBoston Scientific20206—
+8K191392AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20198—
+8K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical)20192—
+8K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical)20193—
+8K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…Volcano Corporation20184—
+8K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izVolcano Corporation20152—
+8K150441Volcano iFR Modality, iFR Scout featureVolcano Corporation20159—
+8K143122Volcano iFR Harvest Software (Offline)Volcano Corporation20150—
+9K252238CoroFlow Cardiovascular SystemCoroventis Research AB20250—
+9K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+9K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™…Abbott Medical20230—
+9K220243Ultiri Measurement SystemAbbott Medical20220—
+9K210889iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation20214—
+9K201881CoroFlow Cardiovascular SystemCoroventis Research AB20201—
+9K201713AVVIGO Guidance SystemBoston Scientific Corporation20204—
+9K193013AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20207—
+9K190078IntraSightVolcano Corporation20192—
+9K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…Volcano Corporation201701
+9K170133FFR V2.5Philips Volcano201751
+9K170385CORE M2 Vascular SystemVolcano Corporation20171—
+10K253714IntraSight PlusPhilips Image Guided Therapy Corporation202601
+10K212490AVVIGO Guidance System IIBoston Scientific Corporation20213—
+10K210680AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20210—
+10K203719IntraSight MobileVolcano Corporation202101
+10K201015AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20205—
+11K230884AVVIGO'+ Multi-Modality Guidance SystemBoston Scientific Corporation2023122
+11K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+11K212345AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20214—
+12K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific20260—
+12K220784AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20223—
+13K222209AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20222—
+14K231091AcQMap High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20230—
+14K230606AcQMap® High Resolution Imaging and Mapping SystemAcutus Medical, Inc.20230—