Brainlab Elements Image Fusion

GUDID 04056481140816

Brainlab AG

Radiology picture archiving and communication system application software

• Primary Device ID: 04056481140816
• NIH Device Record Key: 5a263fc6-575e-4560-9567-0bb1a1997ac7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brainlab Elements Image Fusion
• Version Model Number: 4.0
• Company DUNS: 314482980
• Company Name: Brainlab AG
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481140816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170816

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2018-10-22
• Device Publish Date: 2018-09-21

On-Brand Devices [Brainlab Elements Image Fusion]

• 04056481140816: 4.0
• 04056481143992: 4.5