SenoIris

GUDID 00840682147767

GE MEDICAL SYSTEMS

Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation Diagnostic x-ray digital imaging system workstation

• Primary Device ID: 00840682147767
• NIH Device Record Key: e98e92dd-5782-467a-98b2-07f4d271e5d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SenoIris
• Version Model Number: 1
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682147767 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160937

FDA Product Code

• LLZ: System, image processing, radiological

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: 2020-07-09
• Device Publish Date: 2020-07-01

Devices Manufactured by GE MEDICAL SYSTEMS

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• 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