Senographe Pristina 3D

GUDID 00195278194039

Kit upgrade HW Single PC Infinity

GE MEDICAL SYSTEMS

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• Primary Device ID: 00195278194039
• NIH Device Record Key: 89f5e87f-5caf-47f6-b245-f3a547868923
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Senographe Pristina 3D
• Version Model Number: ATA2
• Company DUNS: 266062561
• Company Name: GE MEDICAL SYSTEMS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278194039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130020

FDA Product Code

• OTE: Digital breast tomosynthesis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-31
• Device Publish Date: 2021-05-21

On-Brand Devices [Senographe Pristina 3D]

• 00840682120142: ATA1
• 00195278194039: Kit upgrade HW Single PC Infinity