Search Results
Found 1 results
510(k) Data Aggregation
K Number
K161625Device Name
PixelShine
Manufacturer
ALGOMEDICA
Date Cleared
2016-09-19
(98 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
ALGOMEDICA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AlgoMedica PixelShine System 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 3.0 mm The AlgoMedica PixelShine is not intended for use with or for diagnostic interpretation of mammography images.
Device Description
PixelShine is a medical imaging application that can receive, transfer and perform noise reduction of CT DICOM images over a user network. Received images are processed by the PixelShine to reduce noise, thereby enhancing image quality.
Ask a Question
Page 1 of 1