FDA 510(k) Applications for Medical Device Product Code "PSY"

FDA 510(k) Number Applicant Device Name Decision Date
K203364 Barco NV MDPC-8127 04/15/2021
K213883 Hamamatsu Photonics K.K. NanoZoomer S360MD Slide scanner system 09/27/2022
K233027 Hamamatsu Photonics K.K. NanoZoomer S360MD Slide scanner system 12/22/2023
K232833 Indica Labs, Inc. HALO AP Dx 05/07/2024
K190332 Leica Biosystems Imaging, Inc. Aperio AT2 DX System 05/20/2019
K232202 Leica Biosystems Imaging, Inc. Aperio GT 450 DX 04/16/2024
K192259 Philips Electronics Nederland B.V. Philips IntelliSite Pathology Solution 09/20/2019
DEN160056 Philips Medical Systems Nederland B.V. Philips IntelliSite Pathology Solution 04/12/2017
K172174 Philips Medical Systems Nederland B.V. Philips IntelliSite Pathology Solution 10/04/2017
K241871 Philips Medical Systems Nederland B.V. Philips IntelliSite Pathology Solution 12/02/2024
K203845 Philips Medical Systems Nederland B.V. Philips IntelliSite Pathology Solution 09/17/2021
K242848 Philips Medical Systems Nederland B.V. Philips IntelliSite Pathology Solution 5.1 12/10/2024
K243871 Philips Medical Systems Nederland B.V. Philips IntelliSite Pathology Solution 5.1 03/06/2025
K233204 Philips Medical Systems Nederland B.V. Philips IntelliSite Pathology Solution 5.1 06/24/2024
K230839 Proscia, Inc. Concentriq Dx 02/08/2024
K232208 Sectra AB Sectra Digital Pathology Module (Version 3.3) 04/16/2024
K241717 Shandon Diagnostics Limited E1000 Dx Digital Pathology Solution 02/28/2025
K242783 Ventana Medical Systems, Inc. Roche Digital Pathology Dx 12/17/2024
K232879 Ventana Medical Systems, Inc. Roche Digital Pathology Dx (VENTANA DP 200) 06/14/2024


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