510(k) · Cleared
ClearedCardnav
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paieon, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 10, 2012 as substantially equivalent to K110256 (Paieon, Inc., 2011) and 2 other predicates after a 314-day review. Its family tree reaches back 13 generations to 1995. 1 of the 195 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 10, 2012
- Review
- 314 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K935595 (1995). 194 ancestors in all, the oldest K882061 (1988). No later device cites it as a predicate yet. 1 of the 195 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 9 generations between
- 3 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- 1 generation backK110746 4D LV-Analysis 3.0Tomtec Imaging Systems GmbH · 2011
- This deviceK120282 CardnavPaieon, Inc. · 2012
Show all 13 generations
- Root · 13 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 12 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 11 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 10 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 9 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 8 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 6 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 5 generations backK061946 Acuson X300 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK071036 Modification to Acuson X300 Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 3 generations backK072090 Siemens Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007
- 2 generations backK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- 1 generation backK110746 4D LV-Analysis 3.0Tomtec Imaging Systems GmbH · 2011
- This deviceK120282 CardnavPaieon, 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 |
|---|---|---|---|---|---|
| −13 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −12 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −11 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −10 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −9 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −8 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −7 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −6 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −5 | K061946 | Acuson X300 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | 1 |
| −4 | K071036 | Modification to Acuson X300 Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −3 | K072090 | Siemens Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | — |
| −2 | K090461 | Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 | Tomtec Imaging Systems GmbH | 2009 | 1 |
| −1 | K110746 | 4D LV-Analysis 3.0 | Tomtec Imaging Systems GmbH | 2011 | — |
| 0 (this device) | K120282 | Cardnav | Paieon, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 9 | 0 |
| 1995 | 16 | 0 |
| 1996 | 11 | 0 |
| 1997 | 11 | 0 |
| 1998 | 10 | 0 |
| 1999 | 13 | 0 |
| 2000 | 11 | 0 |
| 2001 | 11 | 0 |
| 2002 | 12 | 0 |
| 2003 | 12 | 1 |
| 2004 | 19 | 0 |
| 2005 | 7 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110256 | The IC-Pro SystemSummary page 1…code OWB) Predicate Devices: 1. The IC-PRO System (version 3.5, model B) cleared under K1 10256; 2. The 4D LV-Analysis software cleared under K1 10746; 3. The… | 2011 |
| * | K110746 | 4D LV-Analysis 3.0Summary page 1…O System (version 3.5, model B) cleared under K1 10256; 2. The 4D LV-Analysis software cleared under K1 10746; 3. The syngo Vector Velocity Imaging application cleared wi… | 2011 |
| * | K072090 | Siemens Diagnostic Ultrasound SystemsSummary page 1…Velocity Imaging application cleared with the Diagnostic Ultrasound System with Accessories under K072090; 4. The Cardiac Motion Quantification Plugin (CMQ) which is… | 2007 |
| Kept off the family tree | K103615 | FDA’s K103615 is Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent… Our reading of the summary gave K103615, FDA’s number for Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent… (Alfa Wassermann Diagnostic Technologies, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Cardiac Motion Quantification Plugin (CMQ), part of the QLAB…”. Kept off the family tree. Summary page 1…ation Plugin (CMQ) which is a part of the QLAB software included with the Q-Station cleared under K1 0361 5. Device Description: CardNav (version 1.0) is an image acquisition and processing… | 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 17 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 41 of the 194 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 OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
CardNav, an image acquisition and processing modular software package, is indicated for use as follows:
Assist in projection selection using 3D modeling based on 2D images.
Perform quantitative analysis on coronary veins based on fluoroscopy images.
Assists in device positioning by providing real time localization on predefined roadmaps and live fluoroscopy.
Perform motion analysis on coronary veins based on fluoroscopy images.
To be used in cardiac procedures and off-line for post-procedural analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120282: Cardnav.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120282
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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