# K033488: Cmi Magnetocardiograph

- Pathway: 510(k) (Traditional)
- Applicant: Cmi Cardiomag Imaging, Inc.
- Decided: Jul 7, 2004 after 246 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: 2 generations back to K901215 (1990). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760542: Electrocardiograph (#1505A), Hewlett-Packard Co. (1976) Summary page 1.
- K962764: Neuromag-122, Philips Medical Systems (Cleveland), Inc. (1996) Summary page 1.

## Most influential descendants
- K151135: Model 621/624 Biomagnetometer (2016), 1 descendant of its own
- K121825: CS-Mag II (2013), 1 descendant of its own
- K232823: MCG-S (AM1000) (2024), 0 descendants of its own
- K182571: CardioFlux with Faraday Analytical Cloud (2019), 0 descendants of its own
- K170154: Creavo Vitalscan Magnetocardiograph (2017), 0 descendants of its own

## Indications for use
The CMI Magnetocardiograph is intended for use as a tool that non-invasively measures and displays the magnetic signals produced by the electric currents in the heart.

Source page: https://510kreport.com/device/K033488
Methodology: https://510kreport.com/methodology