PACSgear Enterprise Server

GUDID 00850677007259

Core Server

HYLAND LLC

Radiology PACS software
Primary Device ID00850677007259
NIH Device Record Keyef6653e9-7916-461f-9d3e-9311436c8c9f
Commercial Distribution Discontinuation2020-04-10
Commercial Distribution StatusNot in Commercial Distribution
Brand NamePACSgear Enterprise Server
Version Model Number5.X
Company DUNS079941872
Company NameHYLAND LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850677007259 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-20
Device Publish Date2020-04-10

On-Brand Devices [PACSgear Enterprise Server]

00850677007259Core Server
00850677007419PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data includin
00850677007396PACSgear Enterprise Server is a program that processes DICOM and non-DICOM medical data includin

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