AW

GUDID 00840682102278

GE MEDICAL SYSTEMS

Radiology picture archiving and communication system workstation
Primary Device ID00840682102278
NIH Device Record Keyd0336eb2-6177-4c6f-b074-6df111b7a9bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameAW
Version Model Number4.7
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
GS100840682102278 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-08-01

Devices Manufactured by GE MEDICAL SYSTEMS

00195278866899 - not applicable2024-06-17 Software Pristina 8.4 - ISO file
00195278719812 - not applicable2024-04-19 Software Pristina ME 9.2 - ISO file
00195278534064 - Spine Auto Views2024-03-19 Spine Auto Views Medical Device
00195278795724 - not applicable2024-01-30 Software Pristina 8.3 - ISO file
00195278719263 - Allia2023-12-18 Allia IGS5 UDI
00195278719577 - Allia2023-12-18 Allia IGS3 UDI
00195278719720 - Allia2023-12-18 Allia IGS 7 UDI
00195278719744 - Allia2023-12-18 Allia IGS 7 OR UDI

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