INTUITIVE IMAGING INFORMATICS, LLC

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

ImageQube - B688IMAGEQUBE0 Catalog Number :

Device Description : ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication Sy ImageQube, Intuitive Imaging Informatics Picture Archiving and Communication System (PACS), is a medical imaging information system that securely transmits, receives, and archives digitally transmitted images and provides radiologists access to patient information, medical images, annotated print pages, transcribed reports.

Device Class : 2

Duns Number: 086797144

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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