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510(k) K011273

Device
SI ASCOPE
Applicant
ASTRON CLINICA LIMITED
510(k) number
K011273
Product code
PSN  
Decision
Substantially Equivalent (SESE)
Decision date
2002-02-20
Date received
2001-04-26
Regulation
878.4580
Classification name
Light Based Imaging
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
E.J. Smith
Address
P.O. Box 4341 Crofton MD US 21114 21114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code PSN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230448DeepX DermoSight DermatoscopeDeepx Health, LLC2023-05-17
K213957Demetra Dermatoscope BDEM-01Barco N.V.2022-03-11
K201408Demetra Analytics ToolkitBarco N.V.2021-02-18
K192829Demetra BDEM-01 DermatoscopeBarco N.V.2019-12-13
K180162VivaScope SystemCaliber Imaging & Diagnostics, Inc.2018-05-03
K080788VIVASCOPE SYSTEM, MODEL 1500, 3000Lucid, Inc.2008-09-17
K062736SIASCOPE VAstron Clinica Limited2007-09-14
K040171MICRODERM, MODEL/VERSION 3.5Visiomed AG2004-06-08
K023729SIASCOPE IIAstron Clinica Limited2003-02-03

Legacy Summary#

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FDA Review#

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