The following data is part of a premarket notification filed by Tracinnovations Aps with the FDA for Tcl3 Motion Tracking System.
| Device ID | K203451 |
| 510k Number | K203451 |
| Device Name: | TCL3 Motion Tracking System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Tracinnovations ApS World Trade Center Borupvang 3 DK-2750 Ballerup, DK |
| Contact | Stefan Glimberg |
| Correspondent | Sheila Pickering Sheila Pickering PhD 2081 Longden Circle Los Altos, CA 94024 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-23 |
| Decision Date | 2021-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05745000363018 | K203451 | 000 |
| 05745000363032 | K203451 | 000 |
| 05745000363025 | K203451 | 000 |
| 05745000363001 | K203451 | 000 |
| 05745000363056 | K203451 | 000 |