510(k) · Cleared
ClearedCardiop-B System, Version 2.1
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 Oct 10, 2007 as substantially equivalent to K030139 (Paieon, Inc., 2004) and 2 other predicates after a 26-day review. Its family tree reaches back 5 generations to 1992. 5 of the 51 devices in its family, counting itself, have a Class I recall. 38 later devices descend from it.
- Decided
- Oct 10, 2007
- Review
- 26 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K922804 (1992). 12 ancestors in all. 38 later devices descend from it, 1 citing it directly. 5 of the 51 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK922804 Awos Angiographic WorkstationSiemens Medical Solutions USA, Inc. · 1992
- 4 generations backK982203 Caas II Lva Biplane OptionPie Medical Equipment B.V. · 1998
- 3 generations backK033920 Caas II RvaPie Medical Imaging BV · 2004
- 2 generations backK052988 CAASPie Medical Imaging BV · 2005
- 1 generation backK063344 Caas Qca 3DPie Medical Imaging BV · 2006
- This deviceK072591 Cardiop-B System, Version 2.1Paieon, Inc. · 2007
- Descendant · cites it directly · 37 of its ownK073328 Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008
- Descendant · 2 generations on · 36 of its ownK082907 IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008
- Descendant · 3 generations on · 30 of its ownK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- Descendant · 4 generations on · 15 of its ownK110256 The IC-Pro SystemPaieon, Inc. · 2011
- Descendant · 4 generations on · 13 of its ownK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190106 Intra-Operative Positioning System; Simple Curve…6 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
- K230309 Intra-Operative Positioning System (IOPS®)…7 generations on · 2023
Most influential descendants
Showing 5 of 38 · See all- K073328Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008 · cites it directly37descendants
- K082907IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008 · 2 generations on36descendants
- K083745The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009 · 3 generations on30descendants
- K110256The IC-Pro SystemPaieon, Inc. · 2011 · 4 generations on15descendants
- K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922804 | Awos Angiographic Workstation | Siemens Medical Solutions USA, Inc. | 1992 | — |
| −4 | K982203 | Caas II Lva Biplane Option | Pie Medical Equipment B.V. | 1998 | — |
| −3 | K033920 | Caas II Rva | Pie Medical Imaging BV | 2004 | — |
| −2 | K052988 | CAAS | Pie Medical Imaging BV | 2005 | — |
| −1 | K063344 | Caas Qca 3D | Pie Medical Imaging BV | 2006 | — |
| 0 (this device) | K072591 | Cardiop-B System, Version 2.1 | Paieon, Inc. | 2007 | — |
| +1 | K073328 | Cardiop-B System, Version 2.1 with Lva | Paieon, Inc. | 2008 | — |
| +2 | K082907 | IC-Pro System, Version 3.1.0.4 | Paieon, Inc. | 2008 | — |
| +3 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| +4 | K110256 | The IC-Pro System | Paieon, Inc. | 2011 | — |
| +4 | K100292 | Caas Qva 3D, Caas Qca 3D | Pie Medical Imaging BV | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K030139 | The Cardiop-B SystemSummary page 1…3D Vessel Analysis System Classification Name: 3D Vessel Analysis System Predicate Devices: CardiOp-B cleared for marketing under K030139, QCA-CMS cleared under K993763 and CAAS QCA 3D cleared under K063344 Device Description:… | 2004 |
| * | K993763 | Quantitative Analysis of Coronary Angiograms (Qca)Summary page 1…3D Vessel Analysis System Predicate Devices: CardiOp-B cleared for marketing under K030139, QCA-CMS cleared under K993763 and CAAS QCA 3D cleared under K063344 Device Description: The CardiOp-B System is an image acquisition and proce… | 1999 |
| * | K063344 | Caas Qca 3DSummary page 1…Devices: CardiOp-B cleared for marketing under K030139, QCA-CMS cleared under K993763 and CAAS QCA 3D cleared under K063344 Device Description: The CardiOp-B System is an image acquisition and processing software… | 2006 |
What descends from it? (38)
See all 381 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073328 | Cardiop-B System, Version 2.1 with Lva | 2008 | 37 |
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 · 6 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 · 7 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 · 7 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 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K073328 (Paieon, Inc., 2008) has gone furthest, with 37 descendants of its own.
- 1 other device also cites its predicate K030139.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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/K072591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072591: Cardiop-B System, Version 2.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072591
Report an extraction error
Are you the manufacturer?
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