510(k) · Cleared
ClearedDynamic Coronary Roadmap 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Oct 24, 2017 as substantially equivalent to K170130 (Philips Medical Systems Nederland B.V., 2017) after an 85-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Oct 24, 2017
- Review
- 85 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913770 (1991). 18 ancestors in all, the oldest K852353 (1985). No later device cites it as a predicate yet.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 5 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 4 generations backK052995 Advantage Workstation 4.3.GE Healthcare · 2005 · Recalled
- 3 generations backK092639 Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT…GE Medical Systems SCS · 2009
- 2 generations backK121772 Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1Philips Medical Systems Nederland B.V. · 2013
- 1 generation backK170130 Dynamic Coronary RoadmapPhilips Medical Systems Nederland B.V. · 2017
- This deviceK172307 Dynamic Coronary Roadmap 2.0Philips Medical Systems Nederland B.V. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −5 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −4 | K052995 | Advantage Workstation 4.3. | GE Healthcare | 2005 | 4 |
| −3 | K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova… | GE Medical Systems SCS | 2009 | — |
| −2 | K121772 | Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1 | Philips Medical Systems Nederland B.V. | 2013 | — |
| −1 | K170130 | Dynamic Coronary Roadmap | Philips Medical Systems Nederland B.V. | 2017 | — |
| 0 (this device) | K172307 | Dynamic Coronary Roadmap 2.0 | Philips Medical Systems Nederland B.V. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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.
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 18.3 · 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? (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 |
|---|---|---|---|
| * | K170130 | Dynamic Coronary RoadmapSummary page 4…Dynamic Coronary Roadmap 1.0 Manufacturer: Philips Medical Systems Nederland B.V 510(k) Clearance: K170130 (Jun 02, 2017) Classification Name: Image-intensified fluoroscopic x-ray system… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 6 of the 18 ancestors have a recall of any class.
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. 2017, 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?
Dynamic Coronary Roadmap is intended to assist the physician during percutaneous coronary interventions in correlating the device position to the coronary vasculature, by providing a motion compensated overlay of this coronary vasculature. The FFR/iFR Roadmap feature is intended to assist the physician during percutaneous coronary interventions in relating the intravascular blood pressure measurement to its anatomical location. FFR/iFR roadmap visualizes…
Read the full statement (108 words)
Dynamic Coronary Roadmap is intended to assist the physician during percutaneous coronary interventions in correlating the device position to the coronary vasculature, by providing a motion compensated overlay of this coronary vasculature.
The FFR/iFR Roadmap feature is intended to assist the physician during percutaneous coronary interventions in relating the intravascular blood pressure measurement to its anatomical location. FFR/iFR roadmap visualizes the position of the pressure wire and the coronary artery on an X-ray image at the moment that an intravascular blood pressure measurement was performed as well as the intravascular blood pressure measurement values themselves.
Dynamic Coronary Roadmap is suitable for use with the entire adult human population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172307: Dynamic Coronary Roadmap 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172307
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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