UltraGATEWAY

GUDID 00860002319803

DICOM Router

ULTRARAD CORPORATION

Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software
Primary Device ID00860002319803
NIH Device Record Key53ac32d8-1f0e-4075-9e52-1abe37b493a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraGATEWAY
Version Model Number4.0.10.27
Company DUNS139399021
Company NameULTRARAD CORPORATION
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 Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com
Phone800-527-3779
Emailsales@ultraradcorp.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860002319803 [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 Date2021-04-08
Device Publish Date2021-03-31

On-Brand Devices [UltraGATEWAY]

00860001148527DICOM Router
00860002319803DICOM Router

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