Cleared Traditional

PAPAYA 3D Plus

K150354 · Genoray Co., Ltd. · Radiology
Dec 2015
Decision
302d
Days
Class 2
Risk

About This 510(k) Submission

K150354 is an FDA 510(k) clearance for the PAPAYA 3D Plus, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Genoray Co., Ltd. (Seongnam-City, KR). The FDA issued a Cleared decision on December 10, 2015, 302 days after receiving the submission on February 11, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K150354 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 2015
Decision Date December 10, 2015
Days to Decision 302 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.