Cleared Traditional

PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

K141700 · Genoray Co., Ltd. · Radiology
Oct 2014
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K141700 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. (Tustin, US). The FDA issued a Cleared decision on October 31, 2014, 129 days after receiving the submission on June 24, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K141700 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2014
Decision Date October 31, 2014
Days to Decision 129 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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