510(k) · Cleared
Recalled · Class II · 2022Sync-RX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volcano Corporation · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 12, 2013 as substantially equivalent to K100849 (Sync-Rx, Ltd., 2010) and 1 other predicate after a 119-day review. Its family tree reaches back 9 generations to 1992. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 12, 2013
- Review
- 119 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K922804 (1992). 66 ancestors in all, the oldest K801623 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK922804 Awos Angiographic WorkstationSiemens Medical Solutions USA, Inc. · 1992
- 5 generations between
- 3 generations backK073328 Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008
- 2 generations backK082907 IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008
- 1 generation backK100849 Sync-RX System, Model AS00010Sync-Rx, Ltd. · 2010
- This deviceK132558 Sync-RX SystemVolcano Corporation · 2013
- Descendant · cites it directly · 2 of its ownK151904 SyncVision SystemVolcano Corporation · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK161756 SyncVision SystemVolcano Corporation · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK172574 SyncVision SystemVolcano Corporation · 2017 · Recalled
Show all 9 generations
- Root · 9 generations backK922804 Awos Angiographic WorkstationSiemens Medical Solutions USA, Inc. · 1992
- 8 generations backK982203 Caas II Lva Biplane OptionPie Medical Equipment B.V. · 1998
- 7 generations backK033920 Caas II RvaPie Medical Imaging BV · 2004
- 6 generations backK052988 CAASPie Medical Imaging BV · 2005
- 5 generations backK063344 Caas Qca 3DPie Medical Imaging BV · 2006
- 4 generations backK072591 Cardiop-B System, Version 2.1Paieon, Inc. · 2007
- 3 generations backK073328 Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008
- 2 generations backK082907 IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008
- 1 generation backK100849 Sync-RX System, Model AS00010Sync-Rx, Ltd. · 2010
- This deviceK132558 Sync-RX SystemVolcano Corporation · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K922804 | Awos Angiographic Workstation | Siemens Medical Solutions USA, Inc. | 1992 | — |
| −8 | K982203 | Caas II Lva Biplane Option | Pie Medical Equipment B.V. | 1998 | — |
| −7 | K033920 | Caas II Rva | Pie Medical Imaging BV | 2004 | — |
| −6 | K052988 | CAAS | Pie Medical Imaging BV | 2005 | — |
| −5 | K063344 | Caas Qca 3D | Pie Medical Imaging BV | 2006 | — |
| −4 | K072591 | Cardiop-B System, Version 2.1 | Paieon, Inc. | 2007 | — |
| −3 | 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 | — |
| −1 | K100849 | Sync-RX System, Model AS00010 | Sync-Rx, Ltd. | 2010 | — |
| 0 (this device) | K132558 | Sync-RX System | Volcano Corporation | 2013 | — |
| +1 | K151904 | SyncVision System | Volcano Corporation | 2015 | 1 |
| +2 | K161756 | SyncVision System | Volcano Corporation | 2016 | 1 |
| +3 | K172574 | SyncVision System | Volcano Corporation | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 12 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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.
Planning a device in OWB? 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 18.2 · 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? (2)
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 |
|---|---|---|---|
| * | K100849 | Sync-RX System, Model AS00010Summary page 1…OWB Predicate Devices: The modified Sync-Rx System is claimed to be substantially equivalent to the following legally marketed predicate devices: The Sync-Rx System (K100849) manufactured by Sync-Rx, Ltd. The Artis 0 (K123529) manufactured by Siemens Medical Systems, Inc. Performance Standards: Thi… | 2010 |
| * | K123529 | Artis Q and Q.Zen- Modular Angiographic SystemSummary page 1…aimed to be substantially equivalent to the following legally marketed predicate devices: The Sync-Rx System (K100849) manufactured by Sync-Rx, Ltd. The Artis 0 (K123529) manufactured by Siemens Medical Systems, Inc. Performance Standards: This 51 0(k) submission was written in accordance with the… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151904 | SyncVision System | 2015 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 19, 2022 | Class II | Z-0885-2022 | Device Design | If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 15 of the 66 ancestors have a recall of any class.
- Of its descendants, K151904 (Volcano Corporation, 2015) has gone furthest, with 2 descendants of its own.
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. 2013, 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?
The Sync-Rx System is an image acquisition and processing system. It is indicated for use as follows:
a) To provide quantitative information regarding the calculated dimensions of arterial segments.
b) To enhance visualization of the stent deployment region.
c) To be used in-procedure in the catheterization lab and off-line for post-procedural analysis.
d) To obtain a co-registration of an anglographic x-ray image and IVUS images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132558: Sync-RX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132558
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