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
+1K130842Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura…Philips Medical Systems Nederland B.V.20130Class I
+1K070834CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations)Omega Medical Imaging, Inc.20079—
+1K062647E-View Fluoroscopy System, Model CS-50Omega Medical Imaging, Inc.200610—
+1K042961Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc.20051361
+1K041780New BridMedical Imaging Solutions, Inc.20040—
+1K031836Philips Fresco Release 1Philips Medical Systems North America Co.200351—
+1K020055Philips Integris Allura 9 with FD OptionPhilips Medical Systems20021242
+1K991922Digital Imaging System (BSR)Siemens Medical Solutions USA, Inc.19990—
+2K130003Xiralite Flourescence Imaging System X4Mivenion GmbH20140—
+2K121296Interventional WorkspotPhilips Medical Systems Nederland B.V.20131—
+2K100371Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc.201116—
+2K100102CS-Series-FPOmega Medical Imaging, Inc.20108—
+2K100468Zeiss Infrared 800 with Flow 800 OptionCarl Zeiss Surgical GmbH20104—
+2K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+2K073130Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.200820—
+2K073088Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.2008119—
+2K071619Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.2007263
+2K072222Spy Fluorescent Imaging SystemNovadaq Technologies, Inc.20071291
+2K071037Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc.20071311
+2K063345Spy Imaging SystemNovadaq Technologies, Inc.20071311
+2K062650EP Navigator SoftwarePhilips Medical Systems200649—
+2K061871Leica Model FL800Leica Microsystems, Inc.2006133—
+2K060867Spy Intraoperative Imaging SystemNovadaq Technologies, Inc.20061341
+2K022899Philips Integris Allura Flat Detector Release 1.0Philips Medical Systems North America Co.20021148
+3K231986Modus IRSynaptive Medical, Inc.20240—
+3K231075Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)Carl Zeiss Meditec, Inc.20230—
+3K202391DIR 800Aesculap, Inc.20211—
+3K182907SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201914—
+3K181177Interventional WorkspotPhilips Medical Systems Nederland B.V.20180—
+3K170239Leica FL560Leica Microsystems (Schweiz) AG20170—
+3K163622Lung VisionBodyvision Medical, Ltd.20176—
+3K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, Inc.2017101
+3K150018VS3-IR-MMS SystemVisionsense, Ltd.2015353
+3K141136Leica FL800Leica Biosystems Richmond20143—
+3K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC20127—
+3K110480Pde Photodynamic EyeHamamatsu Photonics K.K.201213—
+3K101311EP Navigator R3Philips Medical Systems North America Co.201041—
+3K091515Spy Scope Intra-Operative Operating SystemNovadaq Technologies, Inc.20091061
+3K080612Leica FL800Leica Microsystems (Schweiz) AG20089—
+3K031333Philips Integris Allura Flat Detector Release 1.2Philips Medical Systems North America, Inc.200311325
+4K243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)20250—
+4K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+4K214097Explorer Air IISurgvision GmbH20222—
+4K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+4K192761Asimov-MKS Imaging SystemOnlume, Inc.20200—
+4K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20199—
+4K190772SURGICAL MICROSCOPE SYSTEM ORBEYE with IROlympus Medical Systems Corp.20190—
+4K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC20194—
+4K172418OpenSightNovarad Corporation20185—
+4K181537GLOW800Leica Microsystems (Schweiz) AG20180—
+4K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC20181—
+4K150956PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.2016701
+4K152204VS3-IR systemVisionsense, Ltd.201534—
+4K143474Artemis Hand Held Imaging SystemQuest Medical Imaging201501
+4K142126EP Navigator Rel. 5.0Philips Medical Systems Nederland B.V.20140—
+4K133719Pde-NeoHamamatsu Photonics K.K.201411—
+4K133385Lungpoint Atv Planning and Navigation SoftwareBroncus Medical, Inc.20140—
+4K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V.201139—
+4K101077DA Vinci Fluorescence Imaging Vision System, Model FF 100Intuitive Surgical, Inc.20111042
+4K041949Allura Xper FD10Philips Medical Systems North America Co.20046448
+5K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+5K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+5K222240Explorer Air® IISurgvision GmbH20231—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K213128IntraOp VSP Software DeviceXironetic, LLC20221—
+5K220146VisARNovarad Corporation20220—
+5K212890Nyquist.IQOmega Medical Imaging, LLC20210—
+5K212336Soteria.AIOmega Medical Imaging, LLC20211—
+5K202582Arthrex SynergyID Endoscopic Imaging SystemArthrex, Inc.20215—
+5K201172CFP-3131, CFP-2222Mx Imaging, Inc.20200—
+5K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+5K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+5K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™…Omega Medical Imaging, LLC20190—
+5K182606PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies Ulc. (Now A Part of Stryker)201844—
+5K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker2018331
+5K170641da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesIntuitive Surgical, Inc.20170—
+5K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201732—
+5K161792PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc.201668—
+5K141077DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc.2014872
+5K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+5K140138Heartnavigator Release 2.0Philips Medical Systems Nederland B.V.20142—
+5K124031DA Vinci Fluorescence Imaging Vision SystemIntuitive Surgical, Inc.2013103—
+5K130638Alluraclarity Xper FD Series X-Ray SystemPhilips Medical Systems Nederland B.V.20131839
+5K121781Echonavigator Release 1Philips Medical Systems Nederland B.V.201232—
+5K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc.20102439
+5K092713Spectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging201001
+5K082907IC-Pro System, Version 3.1.0.4Paieon, Inc.200836—
+6K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+6K2603184K NIR/ICG Imaging SystemZhejiang Healnoc Technology Co., Ltd.20260—
+6K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+6K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+6K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+6K243884TavipilotCaranx Medical20250—
+6K243069Lumys (V1)Intradys20250—
+6K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+6K242488Soteria E-ViewOmega Medical Imaging, LLC20250—
+6K233840Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)Zhuhai Dipu Medical Technology Co., Ltd.20240—
+6K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+6K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc.2024116
+6K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—