AccessGUDID - DEVICE: TCL3 Motion Tracking System (05745000363001)

GUDID

Device Identifier (DI) Information

Brand Name: TCL3 Motion Tracking System
Version or Model: TCL3.2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tracinnovations A/S

Primary DI Number: 05745000363001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305647222 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47816	Radiological video camera patient positioning/tracking system	An assembly of hardware and software devices intended to use light-based (e.g., infrared, visible light) image acquisition to create three-dimensional (3-D) surfaces of a patient anatomy (e.g., head) to monitor patient position during diagnostic imaging, radiation treatment planning, and/or radiation therapy without the use of patient markers. It includes a camera(s), workstation, and appropriate software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNH	System, Nuclear Magnetic Resonance Imaging

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203451	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Height: 800 Millimeter
Width: 460 Millimeter
Depth: 310 Millimeter

Device Record Status

Public Device Record Key: f8a5e2b0-6f36-4bc6-a06e-ece604417f93
Public Version Date: October 11, 2021
Public Version Number: 1
DI Record Publish Date: October 01, 2021