Cleared Traditional

PAPAYA & PAPAYA Plus

K220423 · Genoray Co., Ltd. · Radiology
May 2022
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K220423 is an FDA 510(k) clearance for the PAPAYA & PAPAYA Plus, 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 May 19, 2022, 94 days after receiving the submission on February 14, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K220423 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2022
Decision Date May 19, 2022
Days to Decision 94 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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