510(k) Report

Devices descending from K926258

382 later devices reach DLX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K251827Azurion R3.1Philips Medical Systems B.V.20251—
+10K243069Lumys (V1)Intradys20250—
+10K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+10K242551syngo Dynamics (Version VA41D)Siemens Healthcare GmbH20251—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K232189OrionXRHoth Intelligence, Inc.20230—
+10K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+10K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+10K200713EchoNavigatorPhilips Medical Systems Nederland B.V.20202—
+10K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+10K172863Infinix-i, INFX-8000V, V7.0Toshibamedical Systems Corporation20175—
+10K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…Philips Health Care20172831
+10K170909Infinix INFX-8000V, V6.40Toshiba Medical Systems Coroporation201705
+10K151780CAAS WorkstationPie Medical Imaging BV20169—
+10K152785XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation201541
+10K143044CAAS A-ValvePie Medical Imaging BV20150—
+10K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+10K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+11K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K253689syngo Dynamics (VA41F)Siemens Healthcare GmbH20260—
+11K254186Azurion R3.1Philips Medical Systems B.V.20260—
+11K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+11K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+11K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+11K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+11K221270EchoNavigator R4.0Philips Medical Systems Nederland B.V.20221—
+11K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+11K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+11K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound…Philips Ultrasound, Inc.20182724
+11K181670Alphenix, INFX-8000V/B, V8.0Canon Medical Systems Corporation201841
+11K180019CAAS WorkstationPie Medical Imaging BV20188—
+11K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+12K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+12K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+12K253614EchoNavigator R5.0Philips Medical Systems Nederland B.V.20260—
+12K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+12K251355X1-FFRSpectrawave, Inc.20250—
+12K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+12K232147CAAS WorkstationPie Medical Imaging BV20241—
+12K233532MULTIX Impact ESiemens Medical Solutions20230—
+12K203551Alphenix, INFX-8000V/B, /S, V9.1Canon Medical Systems Corporation202032
+12K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+12K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+12K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+12K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+13K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+13K243769QFR (3.0)Qfr Solutions BV20250—
+13K233107Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5Canon Medical Systems Corporation202423
+13K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+13K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+13K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+13K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+13K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+14K251602Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve ImagingCanon Medical Systems Corporation20251—
+14K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+14K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+14K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+14K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+14K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+14K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+15K253584Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation20260—
+15K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+15K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+16K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+16K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+16K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+17K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+17K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+17K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+17K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+17K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+17K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+18K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+18K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+18K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+18K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+19K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+19K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+19K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+20K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—