510(k) Report

510(k) · Cleared

Cleared

Ivus Plus

K024103510(k) TraditionalCleared Jan 24, 200343-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

Indec Systems, Inc. · LLZ System, Image Processing, Radiological

Cleared on Jan 24, 2003 as substantially equivalent to K965223 (Endosonics Corp., 1998) and 4 other predicates after a 43-day review. Its family tree reaches back 2 generations to 1992.

Decided
Jan 24, 2003
Review
43 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K921750 (1992). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1993: 2 other ancestorsK921750 · Cvis Insight Iii System · Cardiovascular Imaging Systems, Inc. · 1992K980851 · Galaxy Intravascular Ultrasound System, Model I5028 · Boston Scientific Corp · 19981990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors K980851 · Galaxy Intravascular Ultrasound System, Model I5028 · Boston Scientific Corp · 1998K921750 · Cvis Insight Iii System · Cardiovascular Imaging Systems, Inc. · 19920
  1. Root · 2 generations backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
  2. 1 generation backK980851 Galaxy Intravascular Ultrasound System, Model I5028Boston Scientific Corp · 1998
  3. This deviceK024103 Ivus PlusIndec Systems, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K921750Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc.1992—
−1K980851Galaxy Intravascular Ultrasound System, Model I5028Boston Scientific Corp1998—
0 (this device)K024103Ivus PlusIndec Systems, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199320
199810
FIG. 1 — Lineage of K024103, 1992–2003Source: 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), 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 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? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K965223Resolve Option for the Oracle in Vision Intravascular Ultrasonic Imaging System
Summary page 1
…hir-ing and Communic;ltion System, Class I1 Scc. 21 C1;R 807.92 Predicate Device: Resolve Option for the Oracle In-Vision Intravascular ImaSing System K965223 and Galaxy Intravascular Ultrasound System K98085 I Manufactured by: Jomed Corporation, 2870 Kilgore Road, Rancho Cordova, CA…
Endosonics Corp.1998—
*K980851Galaxy Intravascular Ultrasound System, Model I5028
Summary page 1
…(K965223), Boston Scientific (formerly CVIS) Insight I1 (K9217.50) with Automatic Pullback Device (K933517) and Longview (K930311) Boston Scientific Galaxy system (K98085 1 ) .**‘“-3 ({$ DEPARTMENT OF “H&HUMAN SERVICES Public He…
Boston Scientific Corp1998—
*K921750Cvis Insight Iii System
Summary page 1
…ston Scientific Place, Natick, MA 01 760-1537 Description of the Device: IVUS Plus will function as an accessory to Clearview and insight (K89 1386 and K921750), Boston Scientific's intravascular ultrasound imaging systems. IVUS Plus adds digital image review capability and full-length lo…
Cardiovascular Imaging Systems, Inc.1992—
*K933517Automatic Pull Back Device
Summary page 1
…ted devices: Endosonics In-Vision (Now called Jomed) with Resolve (K965223), Boston Scientific (formerly CVIS) Insight I1 (K9217.50) with Automatic Pullback Device (K933517) and Longview (K930311) Boston Scientific Galaxy system (K98085 1 ) .**‘“-3 ({$ DEPARTMENT OF “H&H…
Cardiovascular Imaging Systems, Inc.1993—
*K930311Cvis Longview
Summary page 1
…s In-Vision (Now called Jomed) with Resolve (K965223), Boston Scientific (formerly CVIS) Insight I1 (K9217.50) with Automatic Pullback Device (K933517) and Longview (K930311) Boston Scientific Galaxy system (K98085 1 ) .**‘“-3 ({$ DEPARTMENT OF “H&HUMAN SERVICES…
Cardiovascular Imaging Systems, Inc.1993—

Also cleared against K965223: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 11 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
  • None of the 5 ancestors has a recall.
  • 5 other devices also cite its predicate K965223.

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—

What is it indicated for?

It is indicated for use in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy.

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

Also cleared against K965223

5 other devices cite the same predicate.

  • K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation · 20083 recalls
  • K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation · 20082 recalls
  • K061215Volcano S51 Family of Imaging SystemsVolcano Corporation · 2006
  • K051920Volcano S5 Imaging System, Model 804200-001Volcano Corporation · 20051 recall
  • K031148IN-Vision Imaging SystemJomed, Inc. · 2003

More from Indec Systems, Inc.

3 FDA decisions under this applicant name. See the company

  • K092842EchoplaqueIndec Systems, Inc. · 2010
  • K062985Ivus EnhancerIndec Systems, Inc. · 2006

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • 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/K024103 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024103: Ivus Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024103

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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