Horizontal

GUDID 00840682139397

GE MEDICAL SYSTEMS

Stationary mammographic x-ray system, digital

• Primary Device ID: 00840682139397
• NIH Device Record Key: 30c365d2-c487-4587-b934-358cf96f257f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Horizontal
• Version Model Number: JMM1
• 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: 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 Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682139397 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173576

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-09-05
• Device Publish Date: 2018-05-25

Devices Manufactured by GE MEDICAL SYSTEMS

• 00198953109281 - Senographe Pristina: 2025-12-09 Senographe Pristina UDI
• 10198953054311 - not applicable: 2025-12-08 UDI Software Pristina
• 00198953076873 - SenoIris: 2025-12-02 SenoIris 1 SP5 Software and Manual
• 00195278914026 - Senographe Pristina: 2025-01-17 Senographe Pristina UDI
• 00195278925428 - Pristina Paddle: 2025-01-17 Small Square presurgical localization paddle - Labelled
• 10195278901764 - Not Applicable: 2025-01-17 Software Pristina 9 - ISO file
• 00195278866899 - not applicable: 2024-06-17 Software Pristina 8.4 - ISO file
• 00195278719812 - not applicable: 2024-04-19 Software Pristina ME 9.2 - ISO file