Cleared Traditional

GenX-CR

K232158 · Genoray Co., Ltd. · Radiology
Sep 2023
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K232158 is an FDA 510(k) clearance for the GenX-CR, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Genoray Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 13, 2023, 55 days after receiving the submission on July 20, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K232158 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2023
Decision Date September 13, 2023
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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