Cleared Traditional

PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2

K031333 · Philips Medical Systems North America, Inc. · Radiology
May 2003
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K031333 is an FDA 510(k) clearance for the PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Philips Medical Systems North America, Inc. (Da Best, NL). The FDA issued a Cleared decision on May 13, 2003, 15 days after receiving the submission on April 28, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K031333 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2003
Decision Date May 13, 2003
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZI — System, X-ray, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1600

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