Cleared Traditional

PORTABLE X-RAY SYSTEM, MODEL PORT-X II

K063121 · Genoray Co., Ltd. · Radiology
Jan 2007
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K063121 is an FDA 510(k) clearance for the PORTABLE X-RAY SYSTEM, MODEL PORT-X II, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Genoray Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on January 11, 2007, 91 days after receiving the submission on October 12, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K063121 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 2006
Decision Date January 11, 2007
Days to Decision 91 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code EHD — Unit, X-ray, Extraoral With Timer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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