Eu Mdr Eu Md Class 1 On The Market 🇩🇰 Denmark

TCL3 Motion Tracking System (800 mm, for Siemens Prisma, VPM64)

TracInnovations A/S · 🇩🇰 Denmark
Devices (same UDI-DI)
6
Certificates
0
Countries
1
Notified Bodies
0

Basic Information

Primary DI
05745000363001
Basic UDI-DI Code
5745000363320WH
Reference
100-0001
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market
Manufacturer
TracInnovations A/S

Additional Description

The TCL3 Motion Tracking System provides quality assurance and assistance for the scanner operators by live monitoring of the patient and real-time motion feedback during MRI examinations. The TCL3 Motion Tracking System can be used for all patient populations when undergoing MRI examinations. It uses a markerless technology, which does not require attaching markers to the patient. Thus, no patient interaction is required, and the system adds minimal changes to the normal clinical workflow. The TCL3 Motion Tracking System monitors the patient’s head for the duration of the scan. It can be turned off between patient scans. While running, the TCL3 Motion Tracking System continuously scans the surface of the patient’s head, producing high-resolution 3D surfaces consisting of thousands of individual points. A structured light technique is utilized, using the combination of a camera and an infrared light modulator to reconstruct 3D surfaces of the patient’s head. Each second, 30 surfaces are created. Each of these surfaces is used for geometric alignment relative to an initial reference position obtained at the beginning of the scan. From these alignments, motion data can be calculated in real-time.

CND Nomenclature Codes

Code Description
V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

Available In Countries

🇩🇰 Denmark

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