Hyland Software Canada ULC

Address:111 Peter Street,Toronto Ontario,CA

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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

NilRead - 00697978970017 Catalog Number :

Device Description : The NilRead software application provides desktop and portable access to multi-m The NilRead software application provides desktop and portable access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data, including mammography and breast tomosynthesis. NilRead also allows users to collaborate by sharing application sessions. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM “for presentation” images must be used.On mobile platforms, this device is not intended for diagnostic use.

Device Class : 2

Duns Number: 203748264

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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