# K031731: MR Fiber Optic Ecg Gating System

- Pathway: 510(k) (Traditional)
- Applicant: Sa Instruments, Inc.
- Decided: Jul 30, 2003 after 56 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. The FDA summary names its predicate without a number.
- (no number) Gating cable provided by General Electric for the 1.0 T and 1.5 T Signa MR systems: named in the summary without a submission number

## Indications for use
The MR Fiber Optic ECG Gating System would be used when it is necessary to synchronize the MR scanner’s data acquisition with the patient’s electrocardiogram.

Source page: https://510kreport.com/device/K031731
Methodology: https://510kreport.com/methodology