TCL3 Motion Tracking System 700 mm, 9ft, Siemens

Organization name

TracInnovations A/S

SRN

DK-MF-000045887

Manufacturer status

Active

Primary placement in Denmark; available across 6 countries total.

Trade name

TCL3 Motion Tracking System 700 mm, 9ft, Siemens

UDI-DI code

05745000363018

Basic UDI-DI

5745000363320WH

Reference / catalog number

100-0004

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product 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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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European Medical Device Nomenclature — the EU product classification assigned to this device.

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER