510(k) · Cleared
Recalled · Class II · 2025Muse Cardiovascular Information System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Medical Systems Information Techn · DSI Detector And Alarm, Arrhythmia
Cleared on Nov 3, 1999 as substantially equivalent to K980495 (Marquette Medical Systems, Inc., 1998) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 1984. 60 later devices descend from it. It has been recalled once.
- Decided
- Nov 3, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K842308 (1984). 4 ancestors in all. 60 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 1 generation backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- This deviceK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999
- Descendant · cites it directly · 23 of its ownK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
- Descendant · 2 generations on · 22 of its ownK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
- Descendant · cites it directly · 20 of its ownK050614 Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2005 · Recalled
- Descendant · 2 generations on · 19 of its ownK072502 Modification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2007 · Recalled
- Descendant · 2 generations on · 18 of its ownK063628 Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions · 2006 · Recalled
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K023100Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002 · cites it directly23descendants
- K042525Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital Hardcopy…Ge Medical Systems Information Technologies · 2004 · 2 generations on22descendants
- K050614Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2005 · cites it directly20descendants
- K072502Modification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2007 · 2 generations on19descendants
- K063628Centricity Radiology RA600, Cardiology CA1000 and Digital HardcopyGe Healthcare Integrated IT Solutions · 2006 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −1 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | — |
| +1 | K023100 | Accusketch Cardiac Quantitative System W/ Advanced Analysis Components | General Electric Medical Systems Information Techn | 2002 | — |
| +2 | K042525 | Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital… | Ge Medical Systems Information Technologies | 2004 | 3 |
| +1 | K050614 | Muse Cardiology Information System | Ge Medical Systems Information Technologies | 2005 | 1 |
| +2 | K072502 | Modification to: Muse Cardiology Information System | Ge Medical Systems Information Technologies | 2007 | 2 |
| +2 | K063628 | Centricity Radiology RA600, Cardiology CA1000 and Digital Hardcopy | Ge Healthcare Integrated IT Solutions | 2006 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
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 DSI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K980495 | Muse Cardiovascular Information SystemSummary page 1…rmation System Computer, diagnostic, programmable Detector and Alarm, Arrhythmia Classification Name: Computer, Diagnostic, Programmable Classification Number: 74DQK K980495 MUSE Cardiovascular Information System K912829 CardioTrace Cardiac Evaluation System MUSE CV is a large capacity client server b… | 1998 |
| * | K912829 | Cardiotrace Cardiac Evaluation SystemsSummary page 1…ble Detector and Alarm, Arrhythmia Classification Name: Computer, Diagnostic, Programmable Classification Number: 74DQK K980495 MUSE Cardiovascular Information System K912829 CardioTrace Cardiac Evaluation System MUSE CV is a large capacity client server based computer system that accesses, stores, and… | 1991 |
What descends from it? (60)
See all 603 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 25, 2025 | Class II | Z-1938-2025 | Software design | 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 patient data. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 13.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K023100 (General Electric Medical Systems Information Techn, 2002) has gone furthest, with 23 descendants of its own.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (190 words)
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.
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/K992637 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992637: 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/K992637
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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