ViewPoint

GUDID 00840682124454

GE Healthcare GmbH

Radiology PACS software

• Primary Device ID: 00840682124454
• NIH Device Record Key: 14c2ea2d-0f41-4456-ac2e-59a1c3b5eaa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViewPoint
• Version Model Number: 6. ver6.9
• Company DUNS: 507406770
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682124454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162743

FDA Product Code

• LLZ: System, image processing, radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-23
• Device Publish Date: 2017-10-03

On-Brand Devices [ViewPoint]

• 00840682145718: 6. ver11
• 00840682140744: 6. ver10
• 00840682124454: 6. ver6.9
• 00840682119627: 6 ver6.8
• 00840682119610: ver5.6
• 00840682103640: 6 ver 6.7
• 00840682171953: 6. ver12
• 00195278517340: ViewPoint 6 v6.14
• 00195278753472: ViewPoint 6 v6.15