NilRead

GUDID 00697978970017

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.

Hyland Software Canada ULC

Radiology PACS software
Primary Device ID00697978970017
NIH Device Record Keya482fc44-2c71-4a35-88ef-a295f79a228b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNilRead
Version Model NumberNIL-READ-GLB
Company DUNS203748264
Company NameHyland Software Canada ULC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100697978970017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-17
Device Publish Date2020-02-07

Trademark Results [NilRead]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NILREAD
NILREAD
88599460 not registered Live/Pending
Hyland Software, Inc.
2019-08-30

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