N/A

GUDID 00195278560049

Software Pristina 8.1 - ISO file

GE MEDICAL SYSTEMS

Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital Stationary mammographic x-ray system, digital

• Primary Device ID: 00195278560049
• NIH Device Record Key: 96bb3fbf-57e0-4a15-856c-6fb41db4af78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: PRISTINA 2.8
• Company DUNS: 266062561
• Company Name: GE MEDICAL SYSTEMS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278560049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162268

FDA Product Code

• MUE: Full Field Digital, System, X-Ray, Mammographic

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: 2022-12-09
• Device Publish Date: 2022-12-01

Devices Manufactured by GE MEDICAL SYSTEMS

• 00195278719812 - not applicable: 2024-04-19 Software Pristina ME 9.2 - ISO file
• 00195278534064 - Spine Auto Views: 2024-03-19 Spine Auto Views Medical Device
• 00195278795724 - not applicable: 2024-01-30 Software Pristina 8.3 - ISO file
• 00195278719263 - Allia: 2023-12-18 Allia IGS5 UDI
• 00195278719577 - Allia: 2023-12-18 Allia IGS3 UDI
• 00195278719720 - Allia: 2023-12-18 Allia IGS 7 UDI
• 00195278719744 - Allia: 2023-12-18 Allia IGS 7 OR UDI
• 00195278711229 - not applicable: 2023-09-22 UDI Software Pristina