510(k) Report

Devices descending from DEN160056

39 later devices reach Philips IntelliSite Pathology Solution through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241717E1000 Dx Digital Pathology SolutionShandon Diagnostics Limited20250—
+1K233126aetherSlideAetherai Co., Ltd.20240—
+1K213883NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.2022141
+1K212361NovoPathAI, Inc.20220—
+1K210811Dynamyx Digital Pathology SoftwareInspirata, Inc.20220—
+1K201005FullFocusPaige.Ai, Inc.20200—
+1K190332Aperio AT2 DX SystemLeica Biosystems Imaging, Inc.201915—
+1K172922MMPC-4127F1Barco N.V.20170—
+1K172174Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.20178—
+2K251952VirasightVirasoft Corporation20260—
+2K250414CaloPixTribun Health20250—
+2K241273FullFocusPaige.Ai, Inc.20250—
+2K232879Roche Digital Pathology Dx (VENTANA DP 200)Ventana Medical Systems, Inc.202411
+2K232833HALO AP DxIndica Labs, Inc.20240—
+2K232202Aperio GT 450 DXLeica Biosystems Imaging, Inc.202410—
+2K230839Concentriq DxProscia, Inc.20241—
+2K233027NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.20237—
+2K193054Sectra Digital Pathology ModuleSectra AB20200—
+2K192259Philips IntelliSite Pathology SolutionPhilips Electronics Nederland B.V.20197—
+3K253554Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc.20261—
+3K261380Concentriq AP-DxProscia, Inc.20260—
+3K260964NanoZoomer S540MD Slide Scanner SystemHamamatsu Photonics K.K.20260—
+3K253606NanoZoomer S20MD Slide scanner system; NanoZoomer S360MD Slide scanner systemHamamatsu Photonics K.K.20260—
+3K243449Infinitt DPSInfinitt Healthcare Co., Ltd.20250—
+3K252762HALO AP DxIndica Labs, LLC20250—
+3K243391AISight DxPathAI, Inc.20250—
+3K250968PathPresenter Clinical ViewerPathpresenter Corporation20250—
+3K242244Viewer+Lumea, Inc.20250—
+3K2331198MP Color LCD Displays C811W, C811WT, PA27 and PA27TShenzhen Beacon Display Technology Co., Ltd.20240—
+3K242783Roche Digital Pathology DxVentana Medical Systems, Inc.202401
+3K232208Sectra Digital Pathology Module (Version 3.3)Sectra AB20240—
+3K203845Philips IntelliSite Pathology SolutionPhilips Medical Systems Nederland B.V.20214—
+3K203364MDPC-8127Barco N.V.20211—
+4K253561Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc.20260—
+4K242545RadiForce MX317W-PAEizo Corporation20250—
+4K240303MetaLite DX Digital Pathology SoftwareJellox Biotech, Inc.20240—
+4K233204Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V.20242—
+5K242848Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V.20241—
+6K243871Philips IntelliSite Pathology Solution 5.1Philips Medical Systems Nederland B.V.20250—