# K983327: Active Ecg Electrodes Magnetom Vision Systems

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 9, 1998 after 17 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: 1 generation back to K915112 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915112: Magnetom 42 SP,63 SP,Impact, Siemens Medical Solutions USA, Inc. (1991) Summary page 2.

## Indications for use
The Active ECG Electrodes (AECGE) are designed to allow for an optimized ECG acquisition during MR examinations. The small dimensions and the method of placing the AECGE directly above the patient's heart are means of minimizing the interference with the MR system.

Source page: https://510kreport.com/device/K983327
Methodology: https://510kreport.com/methodology