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FDA 510(k) Applications for Medical Device Product Code "PSN"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K011273
ASTRON CLINICA LIMITED
SI ASCOPE
02/20/2002
K023729
ASTRON CLINICA LIMITED
SIASCOPE II
02/03/2003
K062736
ASTRON CLINICA LIMITED
SIASCOPE V
09/14/2007
K201408
Barco NV
Demetra Analytics Toolkit
02/18/2021
K192829
Barco NV
Demetra BDEM-01 Dermatoscope
12/13/2019
K213957
Barco NV
Demetra Dermatoscope BDEM-01
03/11/2022
K180162
Caliber Imaging & Diagnostics, Inc.
VivaScope System
05/03/2018
K230448
DeepX Health LLC
DeepX DermoSight Dermatoscope
05/17/2023
K080788
LUCID, INC.
VIVASCOPE SYSTEM, MODEL 1500, 3000
09/17/2008
K040171
VISIOMED AG
MICRODERM, MODEL/VERSION 3.5
06/08/2004
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