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510(k) Data Aggregation
K Number
K241275Device Name
Histolog® Scanner (Hardware 2.4, Software 3.3)
Manufacturer
SamanTree Medical SA
Date Cleared
2024-08-19
(105 days)
Product Code
OWN
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SamanTree Medical SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Histolog® Scanner is a confocal laser system intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture.
Device Description
The Histolog® Scanner is a digital microscopy scanner for use on excised human tissue. Its operating principle is based on confocal fluorescence microscopy and uses non-ionizing, lowpower optical radiation (Class 1 laser product as per IEC 60825-1:2014-05). The Histolog® Scanner acquires digital images with high, micrometer-range resolution and enables the visualization of tissue microstructures down to the cellular level.
The Histolog® Scanner is based on a massively parallel signal acquisition and processing technology providing fast digital imaging over large areas. Image reconstruction does not involve any image stitching or any other similar image blending algorithms. Each pixel in the image is assigned an intensity value based on the light intensity collected by the detector for this particular position in the scan pattern.
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