TCL3 Motion Tracking System 800 mm, 9ft, Siemens
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Identity
- Trade Name
- TCL3 Motion Tracking System 800 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 EUDAMED100-0001 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
- 05745000363001 EUDAMEDFDA UDI
- Basic UDI-DI
- 5745000363320WH EUDAMED
- Direct Marketing DI
- 05745000363001 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Height — 800 Millimeter FDA UDIWidth — 460 Millimeter FDA UDIDepth — 310 Millimeter FDA UDI
Category: Device sterilization/disinfection container, reusable
TCL3 Motion Tracking System 800 mm, 9ft, Siemens by TracInnovations A/S — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221785 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 5745000363320WH | Class I | Active |
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Manufacturer
- Manufacturer
- TracInnovations A/S
- EUDAMED SRN
- DK-MF-000045887
Sources (3)
- EUDAMED 92e83319-a4bd-4a7d-bd0a-ecf67187b4af 61 fields · synced Jul 14, 2026
- FDA UDI f8a5e2b0-6f36-4bc6-a06e-ece604417f93 35 fields · synced May 30, 2026
- FDA 510(k) K221785 1 fields · synced May 18, 2026