Cleared Traditional

PAPAYA 3D Premium & PAPAYA 3D Premium Plus

K200469 · Genoray Co., Ltd. · Radiology
Sep 2020
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K200469 is an FDA 510(k) clearance for the PAPAYA 3D Premium & PAPAYA 3D Premium Plus, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Genoray Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on September 16, 2020, 203 days after receiving the submission on February 26, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K200469 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2020
Decision Date September 16, 2020
Days to Decision 203 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.