# K143436: InvisionECG System

- Pathway: 510(k) (Traditional)
- Applicant: Invisionheart, Inc.
- Decided: May 21, 2015 after 171 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 K955023 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103640: Midmark Iqecg, Brentwood Medical Technology Corp. (2011) Summary page 4.

## Indications for use
The InvisionECG System is intended to acquire, display and record electrocardiographic information from adult and pediatric patients. The InvisionECG System is intended to be used in a clinical or home environment by trained healthcare professionals.

Source page: https://510kreport.com/device/K143436
Methodology: https://510kreport.com/methodology