510(k) · Cleared
ClearedThe IC-Pro 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 May 27, 2011 as substantially equivalent to K083745 (Paieon, Inc., 2009) and 3 other predicates after a 119-day review. Its family tree reaches back 11 generations to 1993. 1 of the 110 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.
- Decided
- May 27, 2011
- Review
- 119 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K926514 (1993). 94 ancestors in all, the oldest K882061 (1988). 15 later devices descend from it, 4 citing it directly. 1 of the 110 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 7 generations between
- 3 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- This deviceK110256 The IC-Pro SystemPaieon, Inc. · 2011
- Descendant · cites it directly · 10 of its ownK133993 Caas WorkstationPie Medical Imaging · 2014
- Descendant · 2 generations on · 9 of its ownK151780 CAAS WorkstationPie Medical Imaging BV · 2016
- Descendant · 3 generations on · 8 of its ownK180019 CAAS WorkstationPie Medical Imaging BV · 2018
- Descendant · 4 generations on · 4 of its ownK182611 Qangio XA 3DMedis Medical Imaging Systems BV · 2019
- Descendant · 5 generations on · 2 of its ownK210093 AccuFFRangioArteryFlow Technology Co., Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 10 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 9 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 8 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 7 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 6 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 5 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 4 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 3 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- This deviceK110256 The IC-Pro SystemPaieon, Inc. · 2011
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…9 generations back · 2003
Most influential descendants
Showing 5 of 15 · See all- K133993Caas WorkstationPie Medical Imaging · 2014 · cites it directly10descendants
- K151780CAAS WorkstationPie Medical Imaging BV · 2016 · 2 generations on9descendants
- K180019CAAS WorkstationPie Medical Imaging BV · 2018 · 3 generations on8descendants
- K182611Qangio XA 3DMedis Medical Imaging Systems BV · 2019 · 4 generations on4descendants
- K210093AccuFFRangioArteryFlow Technology Co., Ltd. · 2021 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −10 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −9 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −8 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −7 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −6 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −5 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −4 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −3 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −2 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −1 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| 0 (this device) | K110256 | The IC-Pro System | Paieon, Inc. | 2011 | — |
| +1 | K133993 | Caas Workstation | Pie Medical Imaging | 2014 | — |
| +2 | K151780 | CAAS Workstation | Pie Medical Imaging BV | 2016 | — |
| +3 | K180019 | CAAS Workstation | Pie Medical Imaging BV | 2018 | — |
| +4 | K182611 | Qangio XA 3D | Medis Medical Imaging Systems BV | 2019 | — |
| +5 | K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 1 |
| 2004 | 7 | 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 |
|---|---|---|
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K083745 | The IC-Pro System, Model Version 3.2Summary page 1…giography Analysis System Classification Name: Angiographic x-ray system Predicate Devices: The IC-PRO (version 3.2) System cleared under K083745; The Integris 3D-RA system cleared for marketing under K040254;… | 2009 |
| * | K040254 | Integris 3D-RA, Release 4.2Summary page 1…Devices: The IC-PRO (version 3.2) System cleared under K083745; The Integris 3D-RA system cleared for marketing under K040254; The Vitrea 2 medical image processing software cleared under K(040305.… | 2004 |
| * | K040305 | VITREA2 Version 3.5Summary page 1…The Integris 3D-RA system cleared for marketing under K040254; The Vitrea 2 medical image processing software cleared under K(040305. The iConnection PRO Stent Positioning System cleared under K040876; Device Description:… | 2004 |
| * | K040876 | Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareSummary page 1…The Vitrea 2 medical image processing software cleared under K(040305. The iConnection PRO Stent Positioning System cleared under K040876; Device Description: The IC-PRO (version 3.5, model B) system is an image acquisition and… | 2004 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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 · 9 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 22 of the 94 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K133993 (Pie Medical Imaging, 2014) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K083745.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 (131 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.
Assists in projection selection using 3D modeling based on 2D images.
Performs dimensional measurement on DICOM image.
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/K110256 · printed Nov 3, 2026
Cite this page
510(k) Report. “K110256: The IC-Pro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K110256
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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