The following data is part of a premarket notification filed by Track X Technology, Llc with the FDA for Trackx.
| Device ID | K200360 |
| 510k Number | K200360 |
| Device Name: | TrackX |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Track X Technology, LLC 200 Timberhill Place, Suite 223 Chapel Hill, NC 27514 |
| Contact | David Skwerer |
| Correspondent | Calley Herzog Biologics Consulting 1555 King St., Suite 300 Alexandria, VA 22314 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Radiology |
| 510k Review Panel | Radiology |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-13 |
| Decision Date | 2020-03-05 |