Cleared Traditional

INTRAX FILM PROCESSOR

K093503 · Velopex International, Inc. · Radiology
Jan 2010
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K093503 is an FDA 510(k) clearance for the INTRAX FILM PROCESSOR, a Processor, Radiographic-film, Automatic (Class II — Special Controls, product code IXW), submitted by Velopex International, Inc. (St. Cloud, US). The FDA issued a Cleared decision on January 6, 2010, 55 days after receiving the submission on November 12, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1900.

Submission Details

510(k) Number K093503 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2009
Decision Date January 06, 2010
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXW — Processor, Radiographic-film, Automatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1900

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