510(k) · Cleared
ClearedThe IC-Pro System, Model Version 3.2
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 Feb 17, 2009 as substantially equivalent to K082907 (Paieon, Inc., 2008) and 3 other predicates after a 63-day review. Its family tree reaches back 10 generations to 1993. 6 of the 96 devices in its family, counting itself, have a Class I recall. 30 later devices descend from it.
- Decided
- Feb 17, 2009
- Review
- 63 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K926514 (1993). 65 ancestors in all, the oldest K882061 (1988). 30 later devices descend from it, 4 citing it directly. 6 of the 96 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 6 generations between
- 3 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 2 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- This deviceK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- Descendant · cites it directly · 15 of its ownK110256 The IC-Pro SystemPaieon, Inc. · 2011
- Descendant · cites it directly · 13 of its ownK100292 Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010
- Descendant · cites it directly · 11 of its ownK091781 Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009
- Descendant · 2 generations on · 10 of its ownK133993 Caas WorkstationPie Medical Imaging · 2014
- Descendant · 3 generations on · 9 of its ownK151780 CAAS WorkstationPie Medical Imaging BV · 2016
Show all 10 generations
- Root · 10 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 9 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 8 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 7 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 6 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 5 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 4 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 3 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 2 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- This deviceK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…8 generations back · 2003
- K190106 Intra-Operative Positioning System; Simple Curve…3 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…4 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…4 generations on · 2024
Most influential descendants
Showing 5 of 30 · See all- K110256The IC-Pro SystemPaieon, Inc. · 2011 · cites it directly15descendants
- K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV · 2010 · cites it directly13descendants
- K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd. · 2009 · cites it directly11descendants
- K133993Caas WorkstationPie Medical Imaging · 2014 · 2 generations on10descendants
- K151780CAAS WorkstationPie Medical Imaging BV · 2016 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −9 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −8 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −7 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −6 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −5 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −4 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −3 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −2 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −1 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| 0 (this device) | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| +1 | K110256 | The IC-Pro System | Paieon, Inc. | 2011 | — |
| +1 | K100292 | Caas Qva 3D, Caas Qca 3D | Pie Medical Imaging BV | 2010 | — |
| +1 | K091781 | Guided Medical Positioning System (GMPS) | Mediguide, Ltd. | 2009 | — |
| +2 | K133993 | Caas Workstation | Pie Medical Imaging | 2014 | — |
| +3 | K151780 | CAAS Workstation | Pie Medical Imaging BV | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 8 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 1 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 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.
6 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? (4)
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 |
|---|---|---|---|
| * | K082907 | IC-Pro System, Version 3.1.0.4Summary page 1…Angiography Analysis System Classification Name: Angiographic x-ray system Predicate Devices: The IC-PRO (version 3.1) System cleared under K082907; The inReach system cleared for marketing under K08 1379; The… | 2008 |
| * | K081379 | Modification to Inreach SystemSummary page 1…Predicate Devices: The IC-PRO (version 3.1) System cleared under K082907; The inReach system cleared for marketing under K08 1379; The Angio IVUS Mapping System cleared under K060483. The Ost… | 2008 |
| * | K060483 | Volcano Angio-Ivus Mapping (Aim) SystemSummary page 1…The inReach system cleared for marketing under K08 1379; The Angio IVUS Mapping System cleared under K060483. The Ostial PRO Stent Positioning System cleared under K06219… | 2006 |
| * | K062192 | Ostial Pro Stent Positioning SystemSummary page 1…ngio IVUS Mapping System cleared under K060483. The Ostial PRO Stent Positioning System cleared under K062192; Device Description: The IC-PRO (version 3.2) system is an image acquisition and… | 2007 |
What descends from it? (30)
See all 304 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 8 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 3 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 · 4 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 · 4 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 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 17 of the 65 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K110256 (Paieon, Inc., 2011) has gone furthest, with 15 descendants of its own.
- 1 other device also cites its predicate K082907.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows: 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. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image. Performs quantitative analysis of the left…
Read the full statement (114 words)
IC-PRO, an image acquisition and processing modular software package, is indicated for use as follows:
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. Provides quantitative information regarding the calculated dimensions of arterial segments based on the 3D image.
Performs quantitative analysis of the left ventricle based on left ventricular angiograms.
Enhances visualization of the stent deployment region and provides quantitative data based on manual stent tracings
Assist in device positioning by providing real time localization on predefined roadmaps.
To be used in-procedure in the catheterization lab and off-line for post-procedural analysis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083745 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083745: The IC-Pro System, Model Version 3.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083745
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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