510(k) · Cleared
ClearedVolcano Angio-Ivus Mapping (Aim) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Corporation · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 23, 2006 as substantially equivalent to K031148 (Jomed, Inc., 2003) and 1 other predicate after a 119-day review. Its family tree reaches back 3 generations to 1994. 5 of the 39 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it.
- Decided
- Jun 23, 2006
- Review
- 119 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940172 (1994). 7 ancestors in all. 31 later devices descend from it, 2 citing it directly. 5 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 2 generations backK993763 Quantitative Analysis of Coronary Angiograms (Qca)Medis Medical Imaging Systems BV · 1999
- 1 generation backK030139 The Cardiop-B SystemPaieon, Inc. · 2004
- This deviceK060483 Volcano Angio-Ivus Mapping (Aim) SystemVolcano Corporation · 2006
- Descendant · cites it directly · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- Descendant · 2 generations on · 15 of its ownK110256 The IC-Pro SystemPaieon, Inc. · 2011
- Descendant · 2 generations on · 13 of its ownK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
- Descendant · 2 generations on · 11 of its ownK091781 Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009
- Descendant · 3 generations on · 10 of its ownK133993 Caas WorkstationPie Medical Imaging · 2014
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190106 Intra-Operative Positioning System; Simple Curve…4 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…5 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…5 generations on · 2024
- K230309 Intra-Operative Positioning System (IOPS®)…5 generations on · 2023
Most influential descendants
Showing 5 of 31 · See all- K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · cites it directly30descendants
- K110256The IC-Pro SystemPaieon, Inc. · 2011 · 2 generations on15descendants
- K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010 · 2 generations on13descendants
- K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009 · 2 generations on11descendants
- K133993Caas WorkstationPie Medical Imaging · 2014 · 3 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −2 | K993763 | Quantitative Analysis of Coronary Angiograms (Qca) | Medis Medical Imaging Systems BV | 1999 | — |
| −1 | K030139 | The Cardiop-B System | Paieon, Inc. | 2004 | — |
| 0 (this device) | K060483 | Volcano Angio-Ivus Mapping (Aim) System | Volcano Corporation | 2006 | — |
| +1 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| +2 | K110256 | The IC-Pro System | Paieon, Inc. | 2011 | — |
| +2 | K100292 | Caas Qva 3D, Caas Qca 3D | Pie Medical Imaging BV | 2010 | — |
| +2 | K091781 | Guided Medical Positioning System (GMPS) | Mediguide, Ltd. | 2009 | — |
| +3 | K133993 | Caas Workstation | Pie Medical Imaging | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 1 |
| 2021 | 1 | 0 |
| 2023 | 3 | 1 |
| 2024 | 3 | 2 |
| 2025 | 4 | 1 |
| 2026 | 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.
5 devices in this family have a Class I recall. 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K031148 | IN-Vision Imaging SystemSummary page 1…21 CFR 870.2330, Product Code: DXK Predicate Device: The Volcano Angio-IVUS Mapping System is substantially equivalent to the Volcano InVision System cleared under K031148 on May 28, 2003, and the Paieon CardiOp-B System cleared under K030139 on April 2, 2004. Device Description: The Angio-IVUS Mapp… | 2003 |
| * | K030139 | The Cardiop-B SystemSummary page 1…Angio-IVUS Mapping System is substantially equivalent to the Volcano InVision System cleared under K031148 on May 28, 2003, and the Paieon CardiOp-B System cleared under K030139 on April 2, 2004. Device Description: The Angio-IVUS Mapping System is an image acquisition and processing system on the In- Vis… | 2004 |
What descends from it? (31)
See all 312 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 5 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 5 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K083745 (Paieon, Inc., 2009) has gone furthest, with 30 descendants of its own.
- 5 other devices also cite its predicate K031148.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Volcano Angio-IVUS Mapping System is intended to provide a common frame of reference for intravascular ultrasound and angiographic images during diagnostic and/or interventional procedures for the coronary vasculature. The system provides indication of the location of the IVUS cross-sectional imaging plane for any given IVUS image as it relates to a two-dimensional (2D) angiographic image and/or the associated three-dimensional (3D) model formulated from multiple 2D image projections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060483: Volcano Angio-Ivus Mapping (Aim) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060483
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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