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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
K190332
Leica Biosystems Imaging, Inc.
Aperio AT2 DX System
05/20/2019
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
K203845
Philips Medical Systems Nederland B.V.
Philips IntelliSite Pathology Solution
09/17/2021
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