510(k) Report

Devices descending from K002258

399 later devices reach Ultraguide CT-Guide 1010 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K221089P12 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+9K221140P20 Elite Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20220—
+9K212960Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5Canon Medical Systems Corporation202201
+9K210432LELTEK Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20218—
+9K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+9K211527Exo IrisExo Imaging, Inc.20211—
+9K211337DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.20210—
+9K202160Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound…FUJIFILM Sonosite, Inc.20200—
+9K201059S60 Elite Series/S70 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20204—
+9K192107Clarius Ultrasound ScannerClarius Mobile Health Corp.201910—
+9K173244superDimension Navigation System V7.2Covidien, LLC20181—
+9K172993P20 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+9K173058P10 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20171—
+9K092365Inreach System, Model AAS00161-02Superdimension, Ltd.20099—
+9K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+9K082386Inreach Planning LaptopSuperdimension, Ltd.20080—
+10K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd.20261—
+10K251853Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20251—
+10K251192Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+10K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+10K250110Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20250—
+10K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+10K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+10K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+10K241582Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800…Canon Medical Systems Corporation20240—
+10K233195Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20243—
+10K232808Butterfly iQ3 Ultrasound SystemButterfly Network, Inc.20241—
+10K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+10K222596S90 Exp Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20233—
+10K222198Exo Iris (El2001)Exo Imaging, Inc.20220—
+10K222365Leltek Ultrasound Imaging System (Model: LU700 Series)Leltek, Inc.20227—
+10K211665SONON Ultrasound Imaging System, Model: SONON300CHealcerion Co., Ltd.20220—
+10K220490ImaCor Zura Handheld ZHH-010Imacor, Inc.202202
+10K211746Pocket Ultrasound SystemGuangdong Youkey Medical Co., Ltd.20221—
+10K213436Clarius Ultrasound ScannerClarius Mobile Health Corp.20212—
+10K211232Apache Ultrasound SystemAco Healthcare Co., Ltd.20210—
+10K202074Apache Ultrasound System (Model C62)Compal Electronics, Inc.20200—
+10K191394ILLUMISITE PlatformCovidien, LLC201901
+10K182648X5 Series Digital Color Doppler Ultrasound SystemSonoscape Medical Corp.20190—
+10K110256The IC-Pro SystemPaieon, Inc.201115—
+10K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+10K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+10K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+11K263182EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10…Samsung Medison Co., Ltd.20260—
+11K254027Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…Sonoscape Medical Corp.20260—
+11K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+11K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+11K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…Sonoscape Medical Corp.20260—
+11K260846Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.20260—
+11K252148Butterfly Gestational Age ToolButterfly Network, Inc.20260—
+11K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+11K252498Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11…Sonoscape Medical Corp.20250—
+11K250791ASUS Ultrasound Imaging System (LU800 series)Asustek Computer, Inc.20250—
+11K242808Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5Canon Medical Systems Corporation20252—
+11K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+11K242681NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner…Nurodata, Inc.20251—
+11K241161Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound…Leltek, Inc.20243—
+11K231930Digital Ultrasonic Diagnostic Imaging System (Model: F6)Guangdong Youkey Medical Co., Ltd.20240—
+11K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+11K231509Aco Apache Ultrasound SystemAco Healthcare Co., Ltd.20230—
+11K232704Clarius Ultrasound ScannerClarius Mobile Health Corp.20230—
+11K133993Caas WorkstationPie Medical Imaging201410—
+11K120282CardnavPaieon, Inc.20120—
+11K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+11K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+11K113594C-THV SystemPaieon, Inc.20120—
+11K113076Caas a-ValvePie Medical Imaging BV20121—
+12K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+12K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+12K261288Handheld Ultrasound ScannerImgfax CO., LTD.20260—
+12K252709Wireless Probe Type Ultrasound ScannerXuzhou Yongkang Electronic Science Technology Co., Ltd.20260—
+12K253597Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20260—
+12K252074Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound SystemCanon Medical Systems Corporation20250—
+12K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+12K243226Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series)…Leltek, Inc.20251—
+12K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+12K151780CAAS WorkstationPie Medical Imaging BV20169—
+12K143044CAAS A-ValvePie Medical Imaging BV20150—
+12K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+12K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+13K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—
+13K261132Healium Intelliscan LX192LCHealium Intelliscan Corporation20260—
+13K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+13K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+13K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+13K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+13K180019CAAS WorkstationPie Medical Imaging BV20188—
+14K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+14K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+14K251355X1-FFRSpectrawave, Inc.20250—
+14K232147CAAS WorkstationPie Medical Imaging BV20241—
+14K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+15K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+15K243769QFR (3.0)Qfr Solutions BV20250—
+15K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+16K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+16K221711AccuICASArteryFlow Technology Co., Ltd.20230—