AW Server

GUDID 00840682102384

GE MEDICAL SYSTEMS

Radiology PACS software
Primary Device ID00840682102384
NIH Device Record Key03d16ebc-c805-45bf-80b8-899f12da4b90
Commercial Distribution StatusIn Commercial Distribution
Brand NameAW Server
Version Model Number3.2
Company DUNS266062561
Company NameGE MEDICAL SYSTEMS
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682102384 [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 StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-05-23
Device Publish Date2016-08-01

Devices Manufactured by GE MEDICAL SYSTEMS

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00198953076873 - SenoIris2025-12-02 SenoIris 1 SP5 Software and Manual
00195278914026 - Senographe Pristina2025-01-17 Senographe Pristina UDI
00195278925428 - Pristina Paddle2025-01-17 Small Square presurgical localization paddle - Labelled
10195278901764 - Not Applicable2025-01-17 Software Pristina 9 - ISO file
00195278866899 - not applicable2024-06-17 Software Pristina 8.4 - ISO file

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