Cleared Traditional

Ai Ray Dental X-Ray Device

K222569 · Guilin Woodpecker Medical Instrument Co., Ltd. · Radiology
Nov 2022
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K222569 is an FDA 510(k) clearance for the Ai Ray Dental X-Ray Device, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Guilin Woodpecker Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on November 23, 2022, 91 days after receiving the submission on August 24, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K222569 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2022
Decision Date November 23, 2022
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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