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510(k) Data Aggregation
K Number
K100372Device Name
SAFECT MODEL VER 1.0
Manufacturer
MEDIC VISION BRAIN TECHNOLOGIES LTD
Date Cleared
2010-12-14
(305 days)
Product Code
LLZ, 892
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
MEDIC VISION BRAIN TECHNOLOGIES LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SafeCT is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3 mm. The SafeCT is not intended for use with or for diagnostic interpretation of Mammography images.
Device Description
The SafeCT is a software package of a PACS server, which is connected to the clinics' Local Area Network (LAN), receives, processes and transfers CT images, using the DICOM protocol. The processing enhances image quality by reduction of the image noise.
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