Automatic Registration iMRI

GUDID 04056481144845

Automatic Registration iMRI provides an automatic image registration for cranial indications.

Brainlab AG

Electromagnetic/optical surgical navigation device tracking system

• Primary Device ID: 04056481144845
• NIH Device Record Key: 7a936644-c20f-4ab1-8154-a13181cabe5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automatic Registration iMRI
• Version Model Number: 1.1
• 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: false
• 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	04056481144845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223288

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

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: 2023-11-28
• Device Publish Date: 2023-11-20

Devices Manufactured by Brainlab AG

• 04056481140809 - Curve 1.2 Dual Navigation Station: 2025-03-26
• 04056481141677 - Cirq Robotic Disposable Kinematic Unit: 2025-03-26
• 04056481125967 - Patient Mask Set: 2025-03-18
• 04056481142698 - Frameless SRS MASK SET CRANIAL: 2025-03-18
• 04056481142704 - Frameless SRS MASK SET EXTENDED: 2025-03-18
• 04056481145620 - Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm: 2025-03-04
• 04056481145637 - Alignment Guide Tube Cranial 4.9 mm / 8.0 mm: 2025-03-04
• 04056481145903 - Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm: 2025-03-04