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FDA-cleared K161625

PixelShine

ALGOMEDICA

Authorized purpose: PixelShine is intended for networking, communication, processing, and enhancement of CT images in DICOM format to assist professional radiologists and specialists in reaching their own diagnosis. Processing is not effective for lesions, masses, or abnormalities smaller than 3 mm, and the device is not intended for diagnostic interpretation of mammography images.

Modality
CT/CTA
Anatomy
CT images represented in DICOM format
Decision
2016-09-19