# K221785: TCL3 Motion Tracking System

- Pathway: 510(k) (Traditional)
- Applicant: Tracinnovations A/S
- Decided: Aug 29, 2022 after 69 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K971684 (1997). 40 ancestors in all.
No later device cites it as a predicate yet.
6 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203451: TCL3 Motion Tracking System, Tracinnovations Aps (2021) Summary page 4.

## Indications for use
The TCL3 Motion Tracking System is an accessory to a Magnetic Resonance Imaging (MRI) scanner. The system uses a markerless sensor based technology for tracking of patient movement during an MRI session. It provides the current position of the patient in real-time to the MRI scanner. The TCL3 Motion Tracking System is intended to support, supplement, and/or augment the performance of MRI scanners that have been validated for compatibility.

Source page: https://510kreport.com/device/K221785
Methodology: https://510kreport.com/methodology