TrackX Interventional Fluoroscopic X-Ray System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200360 FDA 510(k)
- FDA Product Code
- OWB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1650 FDA 510(k)
- Regulation Number
- 892.1650 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TrackX Interventional Fluoroscopic X-Ray System is a specialized medical imaging device designed for real-time fluoroscopic visualization. It supports interventional radiology procedures by providing live X-ray imaging to guide precise instrument placement and manipulation within the body, enhancing procedural accuracy and safety.
This system is intended for use in radiology settings and is supplied as a reusable medical device. It operates under FDA clearance (510K) and is classified as a Class II device. The system requires proper calibration and maintenance, adhering to regulatory standards for interventional imaging equipment. No specific sterility or single-use designation is indicated in the provided data.
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. Sources consulted: TrackX, TrackX Technology - 2026 Company Profile & Team - Tracxn, TrackX, TrackX Technology, Inc. - LinkedIn, TRACKX TECHNOLOGY LLC in Chapel Hill, NC - Bizapedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200360 | Class II | Active |
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Manufacturer
- Manufacturer
- Track X Technology, LLC
Sources (1)
- FDA 510(k) K200360 24 fields · synced Sep 19, 2026