# K212271: smart-sync

- Pathway: 510(k) (Traditional)
- Applicant: Northh Medical GmbH
- Decided: Feb 4, 2022 after 199 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: 31 generations back to K941811 (1994). 197 ancestors in all.
No later device cites it as a predicate yet.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981190: High Impedance Cardiac Gating Cable, GE Medical Systems (1998) Summary page 4.
- K152330: Expression MR400 MRI Patient Monitoring System, Invivo Corporation (2015) Summary page 4.

## Indications for use
smart-sync is intended to generate a gating signal for MR scanners (1.5T and 3T) for motion compensation by detecting the heartbeat of a patient using Doppler ultrasound. Thus, smart-sync is intended to improve the image quality by reducing movement artefacts for MR images of the whole body, where motion compensation of the heart movement is necessary. smart-sync is intended to be used on pregnant women, where the fetus is examined. smart-sync is also intended to be used for adult MR examinations. smart-sync is not intended to monitor any physiological parameters.

Source page: https://510kreport.com/device/K212271
Methodology: https://510kreport.com/methodology