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TCL3 Motion Tracking System 700 mm, 9ft, Siemens
EUDAMEDFDA UDIClass I (EU MDR)
Ref 100-0004Model TCL3 Motion Tracking System
Identity
- Trade Name
- TCL3 Motion Tracking System 700 mm, 9ft, Siemens EUDAMEDTCL3 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 Motion Tracking System EUDAMED100-0004 EUDAMEDTCL3.2 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
- 05745000363018 EUDAMEDFDA UDI
- Basic UDI-DI
- 5745000363320WH EUDAMED
- Direct Marketing DI
- 05745000363018 EUDAMED
- 510(k) Number
- K203451 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Radiological video camera patient positioning/tracking system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Height — 700 Millimeter FDA UDIWidth — 460 Millimeter FDA UDIDepth — 310 Millimeter FDA UDI
TCL3 Motion Tracking System 700 mm, 9ft, Siemens by TracInnovations A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5745000363320WH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- TracInnovations A/S
- EUDAMED SRN
- DK-MF-000045887
Sources (2)
- EUDAMED 24a536c4-d5cc-48c8-a5ac-473980a90cef 61 fields · synced Jun 19, 2026
- FDA UDI 48bb2bd2-4c63-438c-97f5-4ad7f74ded13 35 fields · synced May 30, 2026