Cleared Traditional

K122928 - DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA

K122928 is the FDA 510(k) clearance for DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA by Rayence Co., Ltd.. It is a Class 2 Radiology device (product code MQB) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K122928 · Rayence Co., Ltd. · Radiology device
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Jan 2013
Decision
128d
Days
Class 2
Risk

K122928 is an FDA 510(k) clearance for the DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Rayence Co., Ltd. (Houston, US). The FDA issued a Cleared decision on January 30, 2013 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Rayence Co., Ltd. devices

Submission Details

510(k) Number K122928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2012
Decision Date January 30, 2013
Days to Decision 128 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
21d slower than avg
Panel avg: 107d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 218
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