Cleared Traditional

PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

K130419 · Genoray Co., Ltd. · Radiology
Nov 2013
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K130419 is an FDA 510(k) clearance for the PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Genoray Co., Ltd. (Orange, US). The FDA issued a Cleared decision on November 6, 2013, 260 days after receiving the submission on February 19, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K130419 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2013
Decision Date November 06, 2013
Days to Decision 260 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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