# K992637: Muse Cardiovascular Information System

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Nov 3, 1999 after 89 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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: 2 generations back to K842308 (1984). 4 ancestors in all.
60 later devices descend from it; 3 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980495: Muse Cardiovascular Information System, Marquette Medical Systems, Inc. (1998) Summary page 1.
- K912829: Cardiotrace Cardiac Evaluation Systems, Cine Graphics, Inc. (1991) Summary page 1.

## Most influential descendants
- K023100: Accusketch Cardiac Quantitative System W/ Advanced Analysis Components (2002), 23 descendants of its own
- K042525: Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy Workstation (2004), 22 descendants of its own
- K050614: Muse Cardiology Information System (2005), 20 descendants of its own
- K072502: Modification to: Muse Cardiology Information System (2007), 19 descendants of its own
- K063628: Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy (2006), 18 descendants of its own

## Recalls of this device
- Apr 25, 2025 · Class II · Z-1938-2025: The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded pati

## Indications for use
MUSE CV is a large capacity client server based computer system that accesses, stores, and manages cardiovascular information. The information can consist of measurements, text, digitized waveforms and angiographic images. MUSE CV is intended to be used in a hospital environment by trained operators. MUSE CV is designed for network compatibility to facilitate retrieval and distribution of cardiovascular information. MUSE CV is designed to interface with other hospital information systems through various communication protocols to support information continuity and results reporting. MUSE CV can provide serial comparison of cardiovascular information to facilitate review of current and previous records. MUSE CV can provide serial trending of cardiovascular information to facilitate review of current and previous records. Through integration with Accusketch (CardioTrace), MUSE aids the physician or trained technologist in providing and documenting an objective quantification of coronary artery stenosis and measurement and quantification of left ventricular function. Also provided is the ability to digitize and store video images and the ability to interactively annotate and report current and post procedural patient cardiac status. Use of MUSE CV is intended for accessing, storage and management of both adult and pediatric cardiovascular information.

Source page: https://510kreport.com/device/K992637
Methodology: https://510kreport.com/methodology