# K173830: MAC VU360 Resting ECG Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Sep 18, 2018 after 274 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K933143 (1994). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142105: Eli 380 Electrocardiograph, Mortara Instrument, Inc. (2014) Summary page 4.

## Most influential descendants
- K203786: MAC 7 - Resting ECG Analysis System (2021), 2 descendants of its own
- K251670: MAC 7 Resting ECG Analysis System (2026), 0 descendants of its own
- K221321: MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System (2022), 0 descendants of its own

## Recalls of this device
- Jun 29, 2026 · Class II · Z-2876-2026: Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a resu
- Aug 22, 2025 · Class II · Z-0231-2026: If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath 
- Oct 27, 2020 · Class II · Z-0543-2021: Incorrect patient identification and/or patient demographic errors.
- Jun 28, 2019 · Class II · Z-2060-2019: Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assig

## Indications for use
The MAC VU360 Resting ECG Analysis System is a non-invasive prescription device. -The device is indicated for use to acquire, analyze, display and print electrocardiograms. -The device is indicated for use to provide interpretation of the data for consideration by a physician. -The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. -The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. -The device is indicated for use on adult and pediatric (birth through 21 years of age) populations.

Source page: https://510kreport.com/device/K173830
Methodology: https://510kreport.com/methodology