Cleared Traditional

RAYSCAN a-Expert

K232325 · Ray Co., Ltd. · Radiology
Apr 2024
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K232325 is an FDA 510(k) clearance for the RAYSCAN a-Expert, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Ray Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on April 18, 2024, 259 days after receiving the submission on August 3, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K232325 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2023
Decision Date April 18, 2024
Days to Decision 259 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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