# K072502: Modification to: Muse Cardiology Information System

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Nov 19, 2007 after 74 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K842308 (1984). 6 ancestors in all.
19 later devices descend from it; 3 cite 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)
- K050614: Muse Cardiology Information System, Ge Medical Systems Information Technologies (2005) Summary page 1.

## Most influential descendants
- K083639: Muse Cardiology Information System with Vmware (2009), 17 descendants of its own
- K110132: Muse Cardiology Information System (2011), 15 descendants of its own
- K133882: Carescape Central Station (Formally Known as Cic Pro) (2014), 9 descendants of its own
- K162012: CARESCAPE Central Station V2 (2016), 7 descendants of its own
- K201941: Monitor B125, Monitor B105 (2020), 3 descendants of its own

## Recalls of this device
- Jan 4, 2012 · Class II · Z-1133-2013: GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment.
- Feb 2, 2009 · Not classified · Z-1719-2009: GE Healthcare has become aware of an issue resulting from a workflow situation related to the automated labeling of patient data in the MUSE Cardiology Information System. When a prior record has been

## 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. 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 primary monitoring. The MUSE Cardiology Information System is not intended for pediatric serial comparison.

Source page: https://510kreport.com/device/K072502
Methodology: https://510kreport.com/methodology