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Allura 3D-Ra Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1

by Philips Medical Systems Nederland B.V.

510(k) K121772

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121772↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Abbreviated NumberK121772 Date21 Mar 2013ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
OWB
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Allura 3D-RA Rel 6, 3D Roadmap Rel 1, and MR-CT Roadmap Rel 1 are interventional fluoroscopic X-ray systems designed for real-time imaging during medical procedures. These devices provide high-resolution 3D imaging capabilities, enabling precise visualization of vascular structures, bone anatomy, and other internal features for interventions such as angiography, cardiac procedures, and orthopedic surgeries.

These systems are intended for use in radiology departments and clinical settings requiring advanced imaging. They are supplied as reusable medical devices and comply with FDA 510(k) clearance and MDR authorizations. The systems are not classified as MRI-safe but are engineered for interventional fluoroscopy applications, with various configurations available to accommodate different procedural needs. Storage and maintenance follow manufacturer guidelines to ensure optimal performance and regulatory compliance.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of medical procedures can the Allura 3D-RA system support with its advanced imaging capabilities?

    The Allura 3D-RA system is designed for real-time interventional fluoroscopy, enabling precise visualization of vascular structures, bone anatomy, and internal features. This makes it particularly useful for procedures like angiography, cardiac interventions, and orthopedic surgeries where detailed 3D imaging is critical for guiding interventions.

  • Are these systems reusable or single-use, and what does that mean for maintenance and cleaning?

    The Allura 3D-RA, 3D Roadmap, and MR-CT Roadmap systems are reusable medical devices. This means they require regular maintenance, cleaning, and sterilization as outlined in the manufacturer’s guidelines to ensure optimal performance, safety, and compliance with regulatory standards.

  • How do I determine which configuration of the Allura system is best suited for my clinical setting?

    The Allura systems come in multiple configurations tailored to different procedural needs. Since the exact specifications aren’t detailed here, you should consult Philips Medical Systems or a specialist to match your facility’s requirements—such as room size, workflow demands, or specific interventional specialties—with the appropriate model.

  • What regulatory pathways have these systems undergone, and how does that affect their use in clinical settings?

    The Allura systems have received FDA 510(k) clearance and MDR authorization, confirming they meet U.S. and EU regulatory standards for safety and effectiveness. This means they can legally be used in approved clinical settings where interventional fluoroscopy is required, provided they are maintained and operated according to manufacturer instructions.

  • Can these systems be used alongside MRI equipment, or are there compatibility concerns?

    The Allura systems are not classified as MRI-safe, meaning they should not be used in direct proximity to MRI equipment due to potential electromagnetic interference or safety risks. They are specifically engineered for interventional fluoroscopy applications and should be installed in dedicated radiology or interventional suites.