Cleared Traditional

PORT CASSETTE

K032654 · Orex Computed Radiography, Ltd. · Radiology
Oct 2003
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K032654 is an FDA 510(k) clearance for the PORT CASSETTE, a System, Imaging, X-ray, Electrostatic (Class II — Special Controls, product code IXK), submitted by Orex Computed Radiography, Ltd. (North Attleboro, US). The FDA issued a Cleared decision on October 9, 2003, 42 days after receiving the submission on August 28, 2003. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1630.

Submission Details

510(k) Number K032654 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2003
Decision Date October 09, 2003
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXK — System, Imaging, X-ray, Electrostatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1630

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