Cleared Traditional

K042334 - ALLURA 3D-CA, RELEASE 1 (FDA 510(k) Clearance)

K042334 · Philips Medical Systems North America Co. · Radiology device

Sep 2004

Decision

28d

Days

Class 2

Risk

K042334 is an FDA 510(k) clearance for the ALLURA 3D-CA, RELEASE 1. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems North America Co. (Bothell, US). The FDA issued a Cleared decision on September 27, 2004, 28 days after receiving the submission on August 30, 2004.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K042334 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 30, 2004
Decision Date	September 27, 2004
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF