TCL3 Motion Tracking System

GUDID 05745000363056

The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session.

Tracinnovations A/S

Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system

• Primary Device ID: 05745000363056
• NIH Device Record Key: ced0f529-5673-47d9-bf9b-0364d8d11b44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TCL3 Motion Tracking System
• Version Model Number: TCL3.2
• Company DUNS: 305647222
• Company Name: Tracinnovations A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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 Dimensions

• Height: 700 Millimeter
• Width: 460 Millimeter
• Depth: 310 Millimeter
• Height: 700 Millimeter
• Width: 460 Millimeter
• Depth: 310 Millimeter
• Height: 700 Millimeter
• Width: 460 Millimeter
• Depth: 310 Millimeter
• Height: 700 Millimeter
• Width: 460 Millimeter
• Depth: 310 Millimeter
• Height: 700 Millimeter
• Width: 460 Millimeter
• Depth: 310 Millimeter
• Height: 700 Millimeter
• Width: 460 Millimeter
• Depth: 310 Millimeter
• Height: 700 Millimeter
• Width: 460 Millimeter
• Depth: 310 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05745000363056 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203451

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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: 2022-06-13
• Device Publish Date: 2022-06-03

On-Brand Devices [TCL3 Motion Tracking System]

• 05745000363018: The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless
• 05745000363032: The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless
• 05745000363025: The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless
• 05745000363001: The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless
• 05745000363056: The TCL3 Motion Tracking System is an accessory to an MRI scanner. The system uses a markerless