Senographe Essential

GUDID 00840682123242

GE MEDICAL SYSTEMS

Stationary mammographic x-ray system, digital
Primary Device ID00840682123242
NIH Device Record Key3fe3ba08-b7a6-46be-87c8-c15aa5105562
Commercial Distribution StatusIn Commercial Distribution
Brand NameSenographe Essential
Version Model NumberES14
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682123242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUEFull field digital,system,x-ray,mammographic

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 Date2016-12-29

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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