Cleared Traditional

PORT-X IV

K172810 · Genoray Co., Ltd. · Radiology
Mar 2018
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K172810 is an FDA 510(k) clearance for the PORT-X IV, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Genoray Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on March 7, 2018, 170 days after receiving the submission on September 18, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K172810 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2017
Decision Date March 07, 2018
Days to Decision 170 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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