Image Fusion

GUDID 04056481145873

Brainlab AG

Stereotactic system application software

• Primary Device ID: 04056481145873
• NIH Device Record Key: eee418df-1aae-4045-97a7-944a86a5cd7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Image Fusion
• Version Model Number: 5.0
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481145873 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243633

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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: 2025-07-04
• Device Publish Date: 2025-06-26

Devices Manufactured by Brainlab AG

• 04056481145330 - CRANIAL 4PI HEADREST PLATFORM: 2025-07-04
• 04056481145347 - CRANIAL 4PI HEAD SUPPORT STANDARD: 2025-07-04
• 04056481145354 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (5 PCS.): 2025-07-04
• 04056481145361 - CRANIAL 4PI WEDGE 10 DEG.: 2025-07-04
• 04056481145378 - CRANIAL 4PI SPACER 20MM: 2025-07-04
• 04056481145453 - CRANIAL 4PI INDEXING PLATE: 2025-07-04
• 04056481145460 - CRANIAL 4PI HEAD SUPPORT WIDE: 2025-07-04
• 04056481145477 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (1 PC.): 2025-07-04