# K121772: Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1

- Pathway: 510(k) (Abbreviated)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Mar 21, 2013 after 279 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K913770 (1991). 16 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040254: Integris 3D-RA, Release 4.2, Philips Medical Systems North America Co. (2004) Summary page 1.
- K092639: Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova Epvision, Model S18751EP, GE Medical Systems SCS (2009) Summary page 1.

## Most influential descendants
- K151598: VesselNavigator Rel. 1.0 (2015), 8 descendants of its own
- K160088: Cydar EV (2016), 7 descendants of its own
- K171829: EndoNaut (2017), 3 descendants of its own
- K212383: EndoNaut (2021), 2 descendants of its own
- K222070: EndoNaut (2022), 1 descendant of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K121772
Methodology: https://510kreport.com/methodology