Cleared Special

K113630 - DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA

K113630 is an FDA 510(k) clearance for DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA, manufactured by Rayence Co., Ltd.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 21-day FDA review.

K113630 · Rayence Co., Ltd. · Radiology device
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Dec 2011
Decision
21d
Days
Class 2
Risk

K113630 is an FDA 510(k) clearance for the DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA. 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 December 29, 2011 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Rayence Co., Ltd. devices

FDA 510(k) Submission Details - K113630

510(k) Number K113630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2011
Decision Date December 29, 2011
Days to Decision 21 days
Submission Type Special
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
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

MQB Device Classification - Class 2, Special Controls

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 387
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