510(k) · Cleared
ClearedThe Cardiop-B System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paieon, Inc. · IZI System, X-Ray, Angiographic
Cleared on Apr 2, 2004 as substantially equivalent to K993763 (Medis Medical Imaging Systems BV, 1999) after a 444-day review. Its family tree reaches back 2 generations to 1994. 5 of the 43 devices in its family, counting itself, have a Class I recall. 40 later devices descend from it.
- Decided
- Apr 2, 2004
- Review
- 444 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940172 (1994). 40 later devices descend from it, 2 citing it directly. 5 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK940172 Cardiovascular Measurement System-CMSMedis Medical Imaging Systems, Inc. · 1994
- 1 generation backK993763 Quantitative Analysis of Coronary Angiograms (Qca)Medis Medical Imaging Systems BV · 1999
- This deviceK030139 The Cardiop-B SystemPaieon, Inc. · 2004
- Descendant · cites it directly · 38 of its ownK072591 Cardiop-B System, Version 2.1Paieon, Inc. · 2007
- Descendant · 2 generations on · 37 of its ownK073328 Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008
- Descendant · 3 generations on · 36 of its ownK082907 IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008
- Descendant · cites it directly · 31 of its ownK060483 Volcano Angio-Ivus Mapping (Aim) SystemVolcano Corporation · 2006
- Descendant · 2 generations on · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190106 Intra-Operative Positioning System; Simple Curve…5 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…6 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…6 generations on · 2024
- K230309 Intra-Operative Positioning System (IOPS®)…6 generations on · 2023
Most influential descendants
Showing 5 of 40 · See all- K072591Cardiop-B System, Version 2.1Paieon, Inc. · 2007 · cites it directly38descendants
- K073328Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008 · 2 generations on37descendants
- K082907IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008 · 3 generations on36descendants
- K060483Volcano Angio-Ivus Mapping (Aim) SystemVolcano Corporation · 2006 · cites it directly31descendants
- K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940172 | Cardiovascular Measurement System-CMS | Medis Medical Imaging Systems, Inc. | 1994 | — |
| −1 | K993763 | Quantitative Analysis of Coronary Angiograms (Qca) | Medis Medical Imaging Systems BV | 1999 | — |
| 0 (this device) | K030139 | The Cardiop-B System | Paieon, Inc. | 2004 | — |
| +1 | K072591 | Cardiop-B System, Version 2.1 | Paieon, Inc. | 2007 | — |
| +2 | K073328 | Cardiop-B System, Version 2.1 with Lva | Paieon, Inc. | 2008 | — |
| +3 | K082907 | IC-Pro System, Version 3.1.0.4 | Paieon, Inc. | 2008 | — |
| +1 | K060483 | Volcano Angio-Ivus Mapping (Aim) System | Volcano Corporation | 2006 | — |
| +2 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 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 |
|---|---|---|---|
| * | K993763 | Quantitative Analysis of Coronary Angiograms (Qca)Summary page 1…Accessory to x-ray angiographic system Predicate Devices: QCA-CMS by MEDIS Medical Imaging Systems Inc. (K993763) Device Description: The CardiOp-B System is an image acquisition and… | 1999 |
What descends from it? (40)
See all 402 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 · 5 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 · 6 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 · 6 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 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 6 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072591 (Paieon, Inc., 2007) has gone furthest, with 38 descendants of its own.
- 4 other devices also cite its predicate K993763.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The CardiOp-B System is a software system that assists in the evaluation of
coronary lesions by enabling the creation of 3D images of coronary vessel
segments based on two to three 2D angiography images obtained from single
plane angiography. CardiOp-B provides quantitative information regarding
the calculated dimensions of arterial segments based on the 3D image.
CardiOp-B is intended for use in real-time in the catheterization lab and off-
line for post-procedural analysis. It is intended for use by clinicians,
technicians and research personnel
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030139 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030139: The Cardiop-B System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030139
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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