SenoIris

GUDID 00198953076873

SenoIris 1 SP5 Software and Manual

GE MEDICAL SYSTEMS

Diagnostic x-ray digital imaging system workstation

• Primary Device ID: 00198953076873
• NIH Device Record Key: b4d6406c-12d6-4b93-9abc-380a7eb3e4e4
• 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	00198953076873 [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: 2025-12-02
• Device Publish Date: 2025-11-24

On-Brand Devices [SenoIris]

• 00840682147767: 1
• 00198953076873: SenoIris 1 SP5 Software and Manual