not applicable

GUDID 00840682146845

Software Pristina Infinity

GE MEDICAL SYSTEMS

Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit Mammographic x-ray system stereotactic unit

• Primary Device ID: 00840682146845
• NIH Device Record Key: 9196767e-dffa-4cf4-a1e8-6c7175733c1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: not applicable
• Version Model Number: PRISTINA 2.0
• 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	00840682146845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162268

FDA Product Code

• OTE: Digital breast tomosynthesis

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-10-25
• Device Publish Date: 2021-02-16

On-Brand Devices [not applicable]

• 00840682145862: PRISTINA 0.0A
• 00840682142373: PRISTINA 0.1
• 00840682143516: PRISTINA 0.0
• 00840682142038: M3-2 SP1 STD+
• 00840682125802: M3-2
• 00840682122603: 5727669
• 00195278009289: PRISTINA 0.0B
• 00840682146845: Software Pristina Infinity
• 00195278716026: UDI Software Pristina ME 9.1
• 00195278655141: Software Pristina 8.2 - ISO file
• 00195278711229: UDI Software Pristina
• 00195278795724: Software Pristina 8.3 - ISO file
• 00195278719812: Software Pristina ME 9.2 - ISO file