Senographe Pristina 3D

GUDID 00195278194039

Kit upgrade HW Single PC Infinity

GE MEDICAL SYSTEMS

Stationary mammographic x-ray system, digital
Primary Device ID00195278194039
NIH Device Record Key89f5e87f-5caf-47f6-b245-f3a547868923
Commercial Distribution StatusIn Commercial Distribution
Brand NameSenographe Pristina 3D
Version Model NumberATA2
Company DUNS266062561
Company NameGE MEDICAL SYSTEMS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100195278194039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OTEDigital breast tomosynthesis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-31
Device Publish Date2021-05-21

On-Brand Devices [Senographe Pristina 3D]

00840682120142ATA1
00195278194039Kit upgrade HW Single PC Infinity

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