510(k) Report

Devices descending from K984545

266 later devices reach Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+9K252010SPY LaparoscopeStryker Endoscopy20250—
+9K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+9K230754L12 LED Light Source with AIMStryker20236—
+9K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+9K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+9K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+9K221611780 nm L11 LED Light Source with AIMStryker202210—
+9K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+9K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+9K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+9K161756SyncVision SystemVolcano Corporation201611
+9K151780CAAS WorkstationPie Medical Imaging BV20169—
+9K143044CAAS A-ValvePie Medical Imaging BV20150—
+9K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+9K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+10K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+10K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+10K242800The 5000 Compact Series Ultrasound SystemsPhilips Ultrasound, LLC20240—
+10K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+10K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+10K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+10K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+10K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+10K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemPhilips Medical Systems20212—
+10K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Medical Systems202117—
+10K180019CAAS WorkstationPie Medical Imaging BV20188—
+10K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+10K172574SyncVision SystemVolcano Corporation201701
+11K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+11K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+11K251355X1-FFRSpectrawave, Inc.20250—
+11K232147CAAS WorkstationPie Medical Imaging BV20241—
+11K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC2024161
+11K231190EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202314
+11K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+11K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+11K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+12K251827Azurion R3.1Philips Medical Systems B.V.20251—
+12K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+12K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+12K243769QFR (3.0)Qfr Solutions BV20250—
+12K240980EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20240—
+12K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202414—
+12K233545EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC202301
+12K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+13K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+13K254186Azurion R3.1Philips Medical Systems B.V.20260—
+13K251455EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+13K250886EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+13K243793EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20250—
+13K251110EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC20250—
+13K243794EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20255—
+13K242020EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20243—
+13K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+13K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+14K260667Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+14K260680EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC202601
+14K253595EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20261—
+14K250177EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20252—
+15K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound…Philips Ultrasound, LLC20260—
+15K262311Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20260—
+15K251651EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC20251—
+16K261211Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…Philips Ultrasound, LLC20260—