510(k) Report

510(k) · Cleared

Cleared

Cardiotrace Cardiac Evaluation Systems

K912829510(k) TraditionalCleared Sep 24, 199190-day reviewClass II21 CFR 892.2050

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

Cine Graphics, Inc. · LLZ System, Image Processing, Radiological

Cleared on Sep 24, 1991 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 61 later devices descend from it.

Decided
Sep 24, 1991
Review
90 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

61 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2002: 1 descendant cleared2004: 1 descendant cleared2006: 3 descendants cleared2005: 2 descendants cleared2003: 1 descendant cleared2011: 2 descendants cleared2014: 4 descendants cleared2007: 1 descendant cleared2008: 2 descendants cleared2012: 5 descendants cleared2015: 4 descendants cleared2009: 1 descendant cleared2010: 1 descendant cleared2013: 4 descendants cleared2016: 6 descendants cleared2018: 4 descendants cleared2017: 2 descendants cleared2024: 3 descendants cleared2020: 3 descendants cleared2021: 1 descendant cleared2022: 3 descendants cleared2025: 4 descendants cleared2023: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK912829 Cardiotrace Cardiac Evaluation SystemsCine Graphics, Inc. · 1991
  2. Descendant · cites it directly · 60 of its ownK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
  3. Descendant · cites it directly · 23 of its ownK023100 Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn · 2002
  4. Descendant · 2 generations on · 22 of its ownK042525 Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity…Ge Medical Systems Information Technologies · 2004 · Recalled
  5. Descendant · 2 generations on · 20 of its ownK050614 Muse Cardiology Information SystemGe Medical Systems Information Technologies · 2005 · Recalled
  6. 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

1999: 12002: 12003: 12004: 12005: 22006: 32007: 12008: 22009: 12010: 12011: 22012: 52013: 42014: 42015: 42016: 62017: 22018: 42020: 32021: 12022: 32023: 12024: 32025: 42026: 1
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 · 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 · 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912829Cardiotrace Cardiac Evaluation SystemsCine Graphics, Inc.1991—
+1K992637Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn19991
+1K023100Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn2002—
+2K042525Centricity Radiology RA600/Centricity Cardiology CA1000/Centricity Digital…Ge Medical Systems Information Technologies20043
+2K050614Muse Cardiology Information SystemGe Medical Systems Information Technologies20051
+3K072502Modification to: Muse Cardiology Information SystemGe Medical Systems Information Technologies20072

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200210
200310
200410
200520
200630
200710
200820
200910
201010
201120
201250
201340
201440
201540
201660
201720
201840
202030
202110
202230
202310
202430
202540
202610
FIG. 1 — Lineage of K912829, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

Planning a device in LLZ? 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 LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (61)

See all 61

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992637Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn199960
K023100Accusketch Cardiac Quantitative System W/ Advanced Analysis ComponentsGeneral Electric Medical Systems Information Techn200223

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?

  • Of its descendants, K992637 (General Electric Medical Systems Information Techn, 1999) has gone furthest, with 60 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

Recent decisions in LLZ

The LLZ category page

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  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K912829 · printed Nov 6, 2026

Cite this page

510(k) Report. “K912829: Cardiotrace Cardiac Evaluation Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912829

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026