510(k) · Cleared
ClearedMuse 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, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Mar 1, 2013 as substantially equivalent to K110132 (Ge Medical Systems Information Technologies, Inc., 2011) after a 38-day review. Its family tree reaches back 7 generations to 1984. 3 later devices descend from it.
- Decided
- Mar 1, 2013
- Review
- 38 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K842308 (1984). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 6 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 5 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 4 generations backK050614 Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 3 generations backK072502 Modification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2007 · Recalled
- 2 generations backK083639 Muse Cardiology Information System with VmwareGe Medical Systems Information Technologies · 2009 · Recalled
- 1 generation backK110132 Muse Cardiology Information SystemGe Medical Systems Information Technologies, Inc. · 2011
- This deviceK130155 Muse Cardiology Information SystemGe Medical Systems Information Technologies, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK152993 MUSE Cardiology Information SystemGe Medical Systems Information Technologies, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK201060 Cordiana Dx16Cordiana Medical Informatics AG · 2020
- Descendant · cites it directly · 0 of its ownK152881 Sentinel Cardiology Information Management SystemSpacelabs Healthcare, Ltd. · 2016 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K152993MUSE Cardiology Information SystemGe Medical Systems Information Technologies, Inc. · 2016 · cites it directly1descendant
- K201060Cordiana Dx16Cordiana Medical Informatics AG · 2020 · 2 generations on0descendants
- K152881Sentinel Cardiology Information Management SystemSpacelabs Healthcare, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −6 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −5 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −4 | 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 |
| −2 | K083639 | Muse Cardiology Information System with Vmware | Ge Medical Systems Information Technologies | 2009 | 1 |
| −1 | K110132 | Muse Cardiology Information System | Ge Medical Systems Information Technologies, Inc. | 2011 | — |
| 0 (this device) | K130155 | Muse Cardiology Information System | Ge Medical Systems Information Technologies, Inc. | 2013 | — |
| +1 | K152993 | MUSE Cardiology Information System | Ge Medical Systems Information Technologies, Inc. | 2016 | 1 |
| +2 | K201060 | Cordiana Dx16 | Cordiana Medical Informatics AG | 2020 | — |
| +1 | K152881 | Sentinel Cardiology Information Management System | Spacelabs Healthcare, Ltd. | 2016 | 2 |
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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2020 | 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 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 |
|---|---|---|---|
| * | K110132 | Muse Cardiology Information SystemSummary page 2…ploys the same functional scientific technology as the predicate device MUSE Cardiovascular Information System (K1 10132). Determination of Substantial Summary of Non-Clinical Tests: Equivalence: The MUSE Cardiology Information System… | 2011 |
What descends from it? (3)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K152993 (Ge Medical Systems Information Technologies, Inc., 2016) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K110132.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 and interpretive 12-lead…
Read the full statement (115 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 and interpretive 12-lead analysis. 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 real-time patient 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/K130155 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130155: Muse Cardiology Information System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130155
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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