510(k) Report

Devices descending from K190332

15 later devices reach Aperio AT2 DX System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232879Roche Digital Pathology Dx (VENTANA DP 200)Ventana Medical Systems, Inc.202411
+1K232202Aperio GT 450 DXLeica Biosystems Imaging, Inc.202410—
+1K210811Dynamyx Digital Pathology SoftwareInspirata, Inc.20220—
+1K193054Sectra Digital Pathology ModuleSectra AB20200—
+2K253554Aperio GT 450 DX; Aperio GT 180 DXLeica Biosystems Imaging, Inc.20261—
+2K261380Concentriq AP-DxProscia, Inc.20260—
+2K251952VirasightVirasoft Corporation20260—
+2K252762HALO AP DxIndica Labs, LLC20250—
+2K243391AISight DxPathAI, Inc.20250—
+2K250414CaloPixTribun Health20250—
+2K241273FullFocusPaige.Ai, Inc.20250—
+2K2331198MP Color LCD Displays C811W, C811WT, PA27 and PA27TShenzhen Beacon Display Technology Co., Ltd.20240—
+2K242783Roche Digital Pathology DxVentana Medical Systems, Inc.202401
+2K232208Sectra Digital Pathology Module (Version 3.3)Sectra AB20240—
+3K253561Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc.20260—