# K203653: MRI PPG Patient Cable

- Pathway: 510(k) (Traditional)
- Applicant: Ivy Biomedical Systems, Inc.
- Decided: Mar 2, 2021 after 77 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MRI PPG Patient Cable is intended to connect to a parent device and facilitate the generation of continuous non-invasive peripheral pulse cardiac gating on adult, pediatric, and neonatal patients in hospital and/or health care environments.

Source page: https://510kreport.com/device/K203653
Methodology: https://510kreport.com/methodology