510(k) · Cleared

Cleared

Muse Cardiovascular Information System

K980495510(k) TraditionalCleared May 7, 199887-day review

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Marquette Medical Systems, Inc. · LOS (no longer in FDA’s product-code list)

Cleared on May 7, 1998 as substantially equivalent to K840932 (Marquette Electronics, Inc., 1984) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1984. 61 later devices descend from it.

Decided: May 7, 1998
Review: 87 days
Product code: LOS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K842308 (1984). 2 ancestors in all. 61 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
This deviceK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
Descendant · cites it directly · 60 of its ownK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
Descendant · 2 generations on · 23 of its ownK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
Descendant · 3 generations on · 22 of its ownK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
Descendant · 2 generations on · 20 of its ownK050614 Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2005 · Recalled
Descendant · 3 generations on · 19 of its ownK072502 Modification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2007 · Recalled

Showing 5 of 61 descendants. See all descendants

Descendants cleared per year

1999high 6 (2016) · low 0 (2000)2026

Most influential descendants

Showing 5 of 61 · See all

K992637Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · cites it directly60descendants
K023100Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002 · 2 generations on23descendants
K042525Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy…Ge Medical Systems Information Technologies · 2004 · 3 generations on22descendants
K050614Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2005 · 2 generations on20descendants
K072502Modification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2007 · 3 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K842308	12SSL-SC	Marquette Electronics, Inc.	1984	—
0 (this device)	K980495	Muse Cardiovascular Information System	Marquette Medical Systems, Inc.	1998	—
+1	K992637	Muse Cardiovascular Information System	General Electric Medical Systems Information Techn	1999	1
+2	K023100	Accusketch Cardiac Quantitative System W/ Advanced Analysis Components	General Electric Medical Systems Information Techn	2002	—
+3	K042525	Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital…	Ge Medical Systems Information Technologies	2004	3
+2	K050614	Muse Cardiology Information System	Ge Medical Systems Information Technologies	2005	1
+3	K072502	Modification to: Muse Cardiology Information System	Ge Medical Systems Information Technologies	2007	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1984	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	1	0
2003	1	0
2004	1	0
2005	2	0
2006	3	0
2007	1	0
2008	2	0
2009	1	0
2010	1	0
2011	2	0
2012	5	0
2013	4	0
2014	4	0
2015	4	0
2016	6	0
2017	2	0
2018	4	0
2020	3	0
2021	1	0
2022	3	0
2023	1	0
2024	3	0
2025	4	0
2026	1	0

FIG. 1 — Lineage of K980495, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LOS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K840932	Muse-DP Summary page 1 …ristin Pabst rade Name: MUSE Cardiovascular Information System Classification Name: Computer, diagnostic, programmable Detector and Alarm, Arrhythmia Marquette MUSE DP K840932 Marquette 12SSL - Serial Comparison ECG Analysis Program K8423008/A MUSE CV is a large capacity client server based computer sy…	Marquette Electronics, Inc.	1984	—
*	K842308	12SSL-SC Our OCR of the scanned summary read K842300, FDA’s number for Onpg Disks (Irvine Diagnostic Services). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Marquette 12SSL - Serial Comparison ECG Analysis Program”.	Marquette Electronics, Inc.	1984	—

Also cleared against K840932: 3 other devices →

What descends from it? (61)

See all 61

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K992637	Muse Cardiovascular Information System	General Electric Medical Systems Information Techn	1999	60

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K992637 (General Electric Medical Systems Information Techn, 1999) has gone furthest, with 60 descendants of its own.
3 other devices also cite its predicate K840932.

What is it indicated for?

The 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, and digitized waveforms. MUSE CV is intended to be used in a hospital environment by trained operators. MUSE CV is designed for network compatibility and interfaces with other hospital information systems through various communication protocols. MUSE CV provides the ability to serially compare/trend cardiovascular information.

Use of MUSE CV is intended for accessing, storage and management of both adult and pediatric cardiovascular information.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980495 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980495: Muse Cardiovascular Information System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980495

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026