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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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