# K232823: MCG-S (AM1000)

- Pathway: 510(k) (Traditional)
- Applicant: Amcg Co., Ltd.
- Decided: Apr 5, 2024 after 205 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K901215 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121825: CS-Mag II, Biomagnetik-Park GmbH (2013) Summary page 7.

## Indications for use
AM1000 is intended for use as a tool which non-invasively measures and displays the magnetic signals produced by the electric currents of the heart.

Source page: https://510kreport.com/device/K232823
Methodology: https://510kreport.com/methodology