510(k) · Cleared
ClearedSync-RX System, Model AS00010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sync-Rx, Ltd. · IZI System, X-Ray, Angiographic
Cleared on May 21, 2010 as substantially equivalent to K082907 (Paieon, Inc., 2008) and 1 other predicate after a 56-day review. Its family tree reaches back 8 generations to 1992. 4 later devices descend from it.
- Decided
- May 21, 2010
- Review
- 56 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K922804 (1992). 26 ancestors in all, the oldest K890348 (1989). 4 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK922804 Awos Angiographic WorkstationSiemens Medical Solutions USA, Inc. · 1992
- 7 generations backK982203 Caas II Lva Biplane OptionPie Medical Equipment B.V. · 1998
- 6 generations backK033920 Caas II RvaPie Medical Imaging BV · 2004
- 5 generations backK052988 CAASPie Medical Imaging BV · 2005
- 4 generations backK063344 Caas Qca 3DPie Medical Imaging BV · 2006
- 3 generations backK072591 Cardiop-B System, Version 2.1Paieon, Inc. · 2007
- 2 generations backK073328 Cardiop-B System, Version 2.1 with LvaPaieon, Inc. · 2008
- 1 generation backK082907 IC-Pro System, Version 3.1.0.4Paieon, Inc. · 2008
- This deviceK100849 Sync-RX System, Model AS00010Sync-Rx, Ltd. · 2010
- Descendant · cites it directly · 3 of its ownK132558 Sync-RX SystemVolcano Corporation · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK151904 SyncVision SystemVolcano Corporation · 2015 · Recalled
- Descendant · 3 generations on · 1 of its ownK161756 SyncVision SystemVolcano Corporation · 2016 · Recalled
- Descendant · 4 generations on · 0 of its ownK172574 SyncVision SystemVolcano Corporation · 2017 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K132558Sync-RX SystemVolcano Corporation · 2013 · cites it directly3descendants
- K151904SyncVision SystemVolcano Corporation · 2015 · 2 generations on2descendants
- K161756SyncVision SystemVolcano Corporation · 2016 · 3 generations on1descendant
- K172574SyncVision SystemVolcano Corporation · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K922804 | Awos Angiographic Workstation | Siemens Medical Solutions USA, Inc. | 1992 | — |
| −7 | K982203 | Caas II Lva Biplane Option | Pie Medical Equipment B.V. | 1998 | — |
| −6 | K033920 | Caas II Rva | Pie Medical Imaging BV | 2004 | — |
| −5 | K052988 | CAAS | Pie Medical Imaging BV | 2005 | — |
| −4 | K063344 | Caas Qca 3D | Pie Medical Imaging BV | 2006 | — |
| −3 | K072591 | Cardiop-B System, Version 2.1 | Paieon, Inc. | 2007 | — |
| −2 | K073328 | Cardiop-B System, Version 2.1 with Lva | Paieon, Inc. | 2008 | — |
| −1 | K082907 | IC-Pro System, Version 3.1.0.4 | Paieon, Inc. | 2008 | — |
| 0 (this device) | K100849 | Sync-RX System, Model AS00010 | Sync-Rx, Ltd. | 2010 | — |
| +1 | K132558 | Sync-RX System | Volcano Corporation | 2013 | 1 |
| +2 | K151904 | SyncVision System | Volcano Corporation | 2015 | 1 |
| +3 | K161756 | SyncVision System | Volcano Corporation | 2016 | 1 |
| +4 | K172574 | SyncVision System | Volcano Corporation | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 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 IZI? 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? (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 |
|---|---|---|---|
| * | K082907 | IC-Pro System, Version 3.1.0.4Summary page 1…Classification: II Classification Panel: Regulation Number: 892.1600 Product Code: IZI Predicate Device: • Paleon IC Pro System v 3.2 system (K082907) manufactured by Paieon, Inc. (USA). * QCA Plus (K915542) manufactured by Sanders Data Systems, (USA). Device Description:… | 2008 |
| * | K915542 | Qca PlusSummary page 1…on Number: 892.1600 Product Code: IZI Predicate Device: • Paleon IC Pro System v 3.2 system (K082907) manufactured by Paieon, Inc. (USA). * QCA Plus (K915542) manufactured by Sanders Data Systems, (USA). Device Description: The Sync-Rx System isan image acquisition and processing workst… | 1992 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132558 | Sync-RX System | 2013 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 8 of the 26 ancestors have a recall of any class.
- Of its descendants, K132558 (Volcano Corporation, 2013) has gone furthest, with 3 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. 2010, 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?
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) Td enhande visualization of the stent deployment region.
c) 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/K100849 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100849: Sync-RX System, Model AS00010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100849
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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