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TCL3 Motion Tracking System

FDA UDI

Class II (US FDA UDI)

by Tracinnovations A/S

Identity

Trade Name
TCL3 Motion Tracking System FDA UDI
Generic Name
Radiological video camera patient positioning/tracking system FDA UDI
Device Name
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. FDA UDI
Model / Reference
TCL3.2 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
05745000363056 FDA UDI
510(k) Number
K203451 FDA UDI
FDA Product Code
LNH FDA UDI
GMDN Term
Radiological video camera patient positioning/tracking system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1000 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Height — 700 Millimeter FDA UDI
Width — 460 Millimeter FDA UDI
Depth — 310 Millimeter FDA UDI

Category: Radiological video camera patient positioning/tracking system

TCL3 Motion Tracking System by Tracinnovations A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiological video camera patient positioning/tracking system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tracinnovations A/S

Sources (1)

  • FDA UDI ced0f529-5673-47d9-bf9b-0364d8d11b44 35 fields · synced May 30, 2026