Cleared Traditional

DVAS (DVAS-M, DVAS-W)

K232085 · Genoray Co., Ltd. · Radiology
Dec 2023
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K232085 is an FDA 510(k) clearance for the DVAS (DVAS-M, DVAS-W), 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 December 8, 2023, 148 days after receiving the submission on July 13, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K232085 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2023
Decision Date December 08, 2023
Days to Decision 148 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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