Cleared Traditional

K130419 - PAPAYA PLUS

K130419 is an FDA 510(k) clearance for PAPAYA PLUS, manufactured by Genoray Co., Ltd.. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 260-day FDA review.

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

K130419 is an FDA 510(k) clearance for the PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Genoray Co., Ltd. (Orange, US). The FDA issued a Cleared decision on November 6, 2013 after a review of 260 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Genoray Co., Ltd. devices

FDA 510(k) Submission Details - K130419

510(k) Number K130419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 107d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUH Device Classification - Class 2, Special Controls

Product Code MUH System, X-ray, Extraoral Source, Digital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUH System, X-ray, Extraoral Source, Digital

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