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510(k) Data Aggregation
K Number
K062736Device Name
SIASCOPE V
Manufacturer
ASTRON CLINICA LIMITED
Date Cleared
2007-09-14
(366 days)
Product Code
PSN
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
ASTRON CLINICA LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SIAscope is a non-invasive skin analysis system, which provides color bitmaps called 'SIAscans' that show the relative location of blood, collagen and pigment.
CAUTION : This device should only be used to scan the patient's skin.
Device Description
The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as 'Spectrophotometric Intracutaneous Analysis' (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin's interior structure.
The SlAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit.
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K Number
K023729Device Name
SIASCOPE II
Manufacturer
ASTRON CLINICA LIMITED
Date Cleared
2003-02-03
(89 days)
Product Code
PSN
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
ASTRON CLINICA LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SIAscope is a non-invasive skin analysis system, which provides a synthesized 'image' showing the relative location of blood collagen and pigment.
Device Description
SIAscope is a non-invasive skin analysis system.
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K Number
K011273Device Name
SI ASCOPE
Manufacturer
ASTRON CLINICA LIMITED
Date Cleared
2002-02-20
(300 days)
Product Code
PSN
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
ASTRON CLINICA LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SIAscope is a self -contained non-invasive skin analysis system, which provides a synthesized 'image' showing the relative location of blood, collagen and pigment.
Device Description
SIAscope is a self -contained non-invasive skin analysis system, which provides a synthesized 'image' showing the relative location of blood, collagen and pigment.
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