510(k) · Cleared
ClearedAllura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1
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 Mar 21, 2013 as substantially equivalent to K040254 (Philips Medical Systems North America Co., 2004) and 1 other predicate after a 279-day review. Its family tree reaches back 5 generations to 1991. 15 later devices descend from it.
- Decided
- Mar 21, 2013
- Review
- 279 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K913770 (1991). 16 ancestors in all, the oldest K852353 (1985). 15 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 3 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 2 generations backK052995 Advantage Workstation 4.3.GE Healthcare · 2005 · Recalled
- 1 generation backK092639 Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT…GE Medical Systems SCS · 2009
- This deviceK121772 Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1Philips Medical Systems Nederland B.V. · 2013
- Descendant · cites it directly · 8 of its ownK151598 VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V. · 2015
- Descendant · 2 generations on · 7 of its ownK160088 Cydar EVCydar, Ltd. · 2016
- Descendant · 3 generations on · 3 of its ownK171829 EndoNautTherenva Sas · 2017
- Descendant · 4 generations on · 2 of its ownK212383 EndoNautTherenva Sas · 2021
- Descendant · 5 generations on · 1 of its ownK222070 EndoNautTherenva Sas · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K151598VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V. · 2015 · cites it directly8descendants
- K160088Cydar EVCydar, Ltd. · 2016 · 2 generations on7descendants
- K171829EndoNautTherenva Sas · 2017 · 3 generations on3descendants
- K212383EndoNautTherenva Sas · 2021 · 4 generations on2descendants
- K222070EndoNautTherenva Sas · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −3 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −2 | K052995 | Advantage Workstation 4.3. | GE Healthcare | 2005 | 4 |
| −1 | K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova… | GE Medical Systems SCS | 2009 | — |
| 0 (this device) | K121772 | Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1 | Philips Medical Systems Nederland B.V. | 2013 | — |
| +1 | K151598 | VesselNavigator Rel. 1.0 | Philips Medical Systems Nederland B.V. | 2015 | — |
| +2 | K160088 | Cydar EV | Cydar, Ltd. | 2016 | — |
| +3 | K171829 | EndoNaut | Therenva Sas | 2017 | — |
| +4 | K212383 | EndoNaut | Therenva Sas | 2021 | — |
| +5 | K222070 | EndoNaut | Therenva Sas | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K040254 | Integris 3D-RA, Release 4.2Summary page 1…Legally marketed devices Trade names: Allura 3D-RA Rel. 4.2 Manufacturer: Philips Medical Systems 510(k) numbers: K040254 - Feb 19, 2004 Trade names: Innova Vision Applications Manufacturer: GE Medical Systems 51… | 2004 |
| * | K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision…Summary page 1…K040254 - Feb 19, 2004 Trade names: Innova Vision Applications Manufacturer: GE Medical Systems 510(k) numbers: K092639 - Dec 2, 2009 // /./ 77… | 2009 |
What descends from it? (15)
See all 154 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 6 of the 16 ancestors have a recall of any class.
- Of its descendants, K151598 (Philips Medical Systems Nederland B.V., 2015) has gone furthest, with 8 descendants of its own.
- 5 other devices also cite its predicate K040254.
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 3D Roadmap Rel. 1 is an extension of Allura 3D-RA, which provides image guidance by superimposing live fluoroscopic images on a 3D reconstruction of the vessel anatomy to assist in catheter maneuvering. The Allura 30-RA Rell. 6 is intended to assist physicians in analyzing two dimensional X-ray images by creating three dimensional views from sets of two dimensional images created during rotational angiographic runs. The Allura 3D-RA Rel. 6 is…
Read the full statement (135 words)
The 3D Roadmap Rel. 1 is an extension of Allura 3D-RA, which provides image guidance by superimposing live fluoroscopic images on a 3D reconstruction of the vessel anatomy to assist in catheter maneuvering.
The Allura 30-RA Rell. 6 is intended to assist physicians in analyzing two dimensional X-ray images by creating three dimensional views from sets of two dimensional images created during rotational angiographic runs.
The Allura 3D-RA Rel. 6 is intended to assist in the diagnosis and treatment of endlovascular diseases, for example, stenosis, aneurysms, and arteriovenous malformations.
The Allura 3D-RA Rel.6 also supports measurement of lesion dimensions and anatomical distances.
The MR-CT Roadmap Rel. 1 s an extension of Allura 30-RA, which provides image guidance by superimposing live fluoroscopic images on a 3D reconstruction of the vessel anatomy to assist in catheter maneuvering.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121772 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121772: Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121772
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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