# K203451: TCL3 Motion Tracking System

- Pathway: 510(k) (Traditional)
- Applicant: Tracinnovations Aps
- Decided: Apr 28, 2021 after 156 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: 17 generations back to K971684 (1997). 39 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193324: Motion Correction System, Kineticor, Inc. (2020) Summary page 4.

## Most influential descendants
- K221785: TCL3 Motion Tracking System (2022), 0 descendants of its own

## 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 MR] scanner. The TCL3 System is intended to support, supplement and/or augment the performance of the Siemens Magnetom Skyra, Siemens Magnetom Prisma, Philips Achieva and GE Signa Premier scanners.

Source page: https://510kreport.com/device/K203451
Methodology: https://510kreport.com/methodology