SenoIris

GUDID 00840682140614

GE Healthcare GmbH

Diagnostic x-ray digital imaging system workstation

• Primary Device ID: 00840682140614
• NIH Device Record Key: 0780ad95-5ece-4cac-bcc8-934dd3859101
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SenoIris
• Version Model Number: 1
• Company DUNS: 342492370
• Company Name: GE Healthcare GmbH
• 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	00840682140614 [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: 2019-06-12
• Device Publish Date: 2019-06-04

Devices Manufactured by GE Healthcare GmbH

• 00195278753472 - ViewPoint: 2024-07-23 ViewPoint 6 v6.15
• 00195278517340 - ViewPoint: 2023-10-18 ViewPoint 6 v6.14
• 00840682171953 - ViewPoint: 2020-08-31
• 00840682145718 - ViewPoint: 2020-01-10
• 00840682140614 - SenoIris: 2019-06-12
• 00840682140614 - SenoIris: 2019-06-12
• 00840682103640 - ViewPoint: 2019-05-23
• 00840682119610 - ViewPoint: 2019-05-23
• 00840682119627 - ViewPoint: 2019-05-23