510(k) · Cleared
Recalled · Class II · 2012Muse Cardiology Information System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · DQK Computer, Diagnostic, Programmable
Cleared on Apr 5, 2005 as substantially equivalent to K992637 (General Electric Medical Systems Information Techn, 1999) after a 26-day review. Its family tree reaches back 3 generations to 1984. 20 later devices descend from it. It has been recalled once.
- Decided
- Apr 5, 2005
- Review
- 26 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K842308 (1984). 5 ancestors in all. 20 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 2 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 1 generation backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- This deviceK050614 Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2005
- Descendant · cites it directly · 19 of its ownK072502 Modification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2007 · Recalled
- Descendant · 2 generations on · 17 of its ownK083639 Muse Cardiology Information System with VmwareGe Medical Systems Information Technologies · 2009 · Recalled
- Descendant · 2 generations on · 15 of its ownK110132 Muse Cardiology Information SystemGe Medical Systems Information Technologies, Inc. · 2011
- Descendant · 3 generations on · 9 of its ownK133882 Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 7 of its ownK162012 CARESCAPE Central Station V2GE Healthcare · 2016 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K072502Modification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2007 · cites it directly19descendants
- K083639Muse Cardiology Information System with VmwareGe Medical Systems Information Technologies · 2009 · 2 generations on17descendants
- K110132Muse Cardiology Information SystemGe Medical Systems Information Technologies, Inc. · 2011 · 2 generations on15descendants
- K133882Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · 3 generations on9descendants
- K162012CARESCAPE Central Station V2GE Healthcare · 2016 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −2 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −1 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| 0 (this device) | K050614 | Muse Cardiology Information System | Ge Medical Systems Information Technologies | 2005 | — |
| +1 | K072502 | Modification to: Muse Cardiology Information System | Ge Medical Systems Information Technologies | 2007 | 2 |
| +2 | K083639 | Muse Cardiology Information System with Vmware | Ge Medical Systems Information Technologies | 2009 | 1 |
| +2 | K110132 | Muse Cardiology Information System | Ge Medical Systems Information Technologies, Inc. | 2011 | — |
| +3 | K133882 | Carescape Central Station (Formally Known as Cic Pro) | Ge Medical Systems Information Technologies, Inc. | 2014 | 1 |
| +3 | K162012 | CARESCAPE Central Station V2 | GE Healthcare | 2016 | 6 |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K992637 | Muse Cardiovascular Information SystemSummary page 1…is Computer Classification Names: 21 CFR 870.1425 Computer, Diagnostic, Programmuable Predicate Device: MUSE Cardiovascular Information System (K992637) Device Desrpto:The MUSE Cardiology Information System comprises a client workstation/server… | 1999 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072502 | Modification to: Muse Cardiology Information System | 2007 | 19 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 4, 2012 | Class II | Z-1133-2013 | Software design | GE Healthcare conducted a recall on the Muse v7 because incorrect medications were displayed on the MUSE, which could result in incorrect treatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K072502 (Ge Medical Systems Information Technologies, 2007) has gone furthest, with 19 descendants of its own.
- 2 other devices also cite its predicate K992637.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
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…
Read the full statement (110 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050614: Muse Cardiology Information System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050614
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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