# K152993: MUSE Cardiology Information System

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Jan 12, 2016 after 91 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K921669 (1993). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130155: Muse Cardiology Information System, Ge Medical Systems Information Technologies, Inc. (2013) Summary page 4.
- K141963: 12SL Ecg Analysis Program, Ge Medical Systems Information Technologies, Inc. (2015) Summary page 4.

## Most influential descendants
- K201060: Cordiana Dx16 (2020), 0 descendants of its own

## Recalls of this device
- Mar 16, 2022 · Class II · Z-0919-2022: Two scenarios may cause edits to measurements and diagnosis statements can be lost after a test is Signed in the MUSE NX web client.

## Indications for use
The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients. The information consists of measurements, text, and digitized waveforms. The MUSE Cardiology Information System provides the ability to review and edit electrocardiographic procedures on screen, through the use of reviewing, measuring, and editing tools including ECG serial comparison and interpretive 12-lead analysis. The MUSE Cardiology Information System is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or facility providing patient care. The MUSE Cardiology Information System is not intended for real-time patient monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.

Source page: https://510kreport.com/device/K152993
Methodology: https://510kreport.com/methodology