510(k) · Cleared
ClearedC-THV 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 Mar 2, 2012 as substantially equivalent to K110256 (Paieon, Inc., 2011) after an 88-day review. Its family tree reaches back 12 generations to 1993. 1 of the 96 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 2, 2012
- Review
- 88 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K926514 (1993). 95 ancestors in all, the oldest K882061 (1988). No later device cites it as a predicate yet. 1 of the 96 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 8 generations between
- 3 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- 1 generation backK110256 The IC-Pro SystemPaieon, Inc. · 2011
- This deviceK113594 C-THV SystemPaieon, Inc. · 2012
Show all 12 generations
- Root · 12 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 11 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 10 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 9 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 8 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 7 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 6 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 5 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 4 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 3 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK083745 The IC-Pro System, Model Version 3.2Paieon, Inc. · 2009
- 1 generation backK110256 The IC-Pro SystemPaieon, Inc. · 2011
- This deviceK113594 C-THV SystemPaieon, Inc. · 2012
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…10 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −11 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −10 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −9 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −8 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −7 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −6 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −5 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −4 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −3 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −2 | K083745 | The IC-Pro System, Model Version 3.2 | Paieon, Inc. | 2009 | — |
| −1 | K110256 | The IC-Pro System | Paieon, Inc. | 2011 | — |
| 0 (this device) | K113594 | C-THV System | Paieon, Inc. | 2012 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K110256 | The IC-Pro SystemSummary page 1…me: Angiographic x-ray system Predicate Devices: The IC-PRO System (version 3.5, model B) cleared under K1 10256; Device Description: The C-THy (version 4.6) system is an image acquisition and… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 10 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 22 of the 95 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K110256.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
C-THY, an image acquisition and processing modular software package, is indicated for use as follows:
C-THY, an image acquisition and processing modular software package, is indicated for use as follows:
* Assists in projection selection using 3D modeling based on 2D images
* Performs dimensional measurements based on DICOM images.
* Assists in device positioning by providing real time localization on predefined roadmaps and live fluoroscopy.
The system is to be used in-procedure and off-line for post-procedural analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113594: C-THV System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113594
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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