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Allura 3D-CA, Release 1

by Philips Medical Systems North America Co.

510(k) K042334

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK042334 Date27 Sep 2004ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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-CA, Release 1 is a diagnostic imaging system used in radiology for visualizing anatomical structures and supporting clinical assessment. It is designed to generate high-resolution three-dimensional images to aid in the evaluation of vascular and cardiac anatomy.

This device is supplied as a reusable system intended for use in clinical imaging environments such as hospitals and diagnostic centers. It is not sterile and does not require sterilization prior to use. The device is authorized under FDA 510(k) clearance K042334 and is subject to applicable U.S. regulatory requirements for medical devices.

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Questions

AI-generated answers, 23 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 is the Allura 3D-CA, Release 1 used for?

    The Allura 3D-CA, Release 1 is a diagnostic imaging system used in radiology to visualize anatomical structures and support clinical assessment by generating high-resolution three-dimensional images, particularly for evaluating vascular and cardiac anatomy.

  • Is the Allura 3D-CA, Release 1 a sterile or single-use device?

    The Allura 3D-CA, Release 1 is supplied as a reusable system and is not sterile; it does not require sterilization prior to use, as it is intended for repeated use in clinical imaging environments such as hospitals and diagnostic centers.

  • How is the Allura 3D-CA, Release 1 supplied and where is it intended for use?

    The device is supplied as a reusable system designed for use in clinical imaging environments, including hospitals and diagnostic centers, where it supports radiology procedures by generating detailed 3D images of patient anatomy.

  • What regulatory authorization does the Allura 3D-CA, Release 1 have?

    The Allura 3D-CA, Release 1 is authorized under FDA 510(k) clearance K042334, which determined it to be substantially equivalent to a legally marketed predicate device, and it is subject to applicable U.S. regulatory requirements for medical devices.