Omni TRAX Active Patient Tracker
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Civco Medical Instruments CO Inc Dba Civco Medical Solutions
Identity
- Trade Name
- omniTRAX Active Patient Tracker EUDAMEDFDA UDI
- Generic Name
- Electromagnetic device tracking system spatial marker FDA UDI
- Device Name
- Electromagnetic Tracking – Tools for Automated Image Fusion (Omnitrax MR) EUDAMEDNon-sterile marker with CIVCO general purpose sensor connection for use in MR and US environments FDA UDI
- Model / Reference
- 610-1306 EUDAMEDFDA UDI
- Description
- Non-sterile marker with CIVCO general purpose sensor connection for use in MR and US environments FDA UDI
Identifiers
- Catalog Number
- 610-1306 FDA UDI
- Primary DI / UDI-DI
- 10841436103128 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD103C2NR EUDAMED
- 510(k) Number
- FDA Product Code
- IYO FDA 510(k)FDA UDILNH FDA UDI
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Electromagnetic device tracking system spatial marker FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)FDA UDI892.1000 FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Width — 3.19 Inch FDA UDILength — 3.39 Inch FDA UDI
The Omni TRAX Active Patient Tracker is a real-time patient positioning and monitoring system designed for use in radiology procedures. It employs active tracking technology to provide precise location data of patients within the imaging field, enhancing safety and accuracy during scans and interventions.
This device is supplied as a reusable system intended for use in radiology departments. It is not sterile and requires proper calibration and maintenance as outlined in the manufacturer’s instructions. The Omni TRAX is approved under FDA 510(k) clearance (K143396) and meets MDR requirements, ensuring compliance with regulatory standards for active patient tracking systems in medical imaging.
Frequently asked questions
What is the Omni TRAX Active Patient Tracker primarily used for in a clinical setting?
The Omni TRAX is designed for real-time patient positioning and monitoring during radiology procedures. It uses active tracking technology to provide precise location data of patients within the imaging field, which helps improve safety and accuracy during scans and interventions by ensuring the patient remains correctly positioned throughout the procedure.
Is the Omni TRAX Active Patient Tracker intended for single-use or reusable applications?
The Omni TRAX is supplied as a reusable system, meaning it is meant to be used repeatedly in radiology departments. However, it is not sterile and requires proper calibration and maintenance as specified in the manufacturer’s instructions to ensure reliable performance over time.
How is the Omni TRAX Active Patient Tracker regulated, and what does that mean for its use?
The Omni TRAX has received FDA 510(k) clearance under the classification of radiology devices (product code IYO) and complies with MDR requirements. This means it has been evaluated for substantial equivalence to a predicate device and meets regulatory standards for active patient tracking systems in medical imaging, ensuring its safety and effectiveness for the intended use in radiology procedures.
What kind of maintenance or calibration does the Omni TRAX require to function properly?
Since the Omni TRAX is a reusable system, it requires regular calibration and maintenance as outlined in the manufacturer’s instructions. Proper upkeep ensures the active tracking technology remains accurate and reliable, which is critical for maintaining patient safety and the precision of radiology procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K143396 | Class II | Active |
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Manufacturer
Sources (3)
- FDA 510(k) K143396 24 fields · synced Oct 6, 2026
- FDA UDI 0302514c-028b-46ad-b344-097a76583ee9 38 fields · synced May 30, 2026
- EUDAMED dc214d10-a6d6-464f-aacc-b911a352276f 61 fields · synced Jul 24, 2026