Cleared Special

K122173 - DIGITAL FLAT PLANEL X-RAY DETECTOR / 17...

K122173 is the FDA 510(k) clearance for DIGITAL FLAT PLANEL X-RAY DETECTOR / 17... by Rayence Co., Ltd.. It is a Class 2 Radiology device (product code MQB) cleared through the Special 510(k) pathway after a 88-day FDA review.

K122173 · Rayence Co., Ltd. · Radiology device
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Oct 2012
Decision
88d
Days
Class 2
Risk

K122173 is an FDA 510(k) clearance for the DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC. 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 October 19, 2012 after a review of 88 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

Submission Details

510(k) Number K122173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2012
Decision Date October 19, 2012
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

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
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K122173.
DIGITAL FLAT PANEL X-RAY DETECTOR / 1012WCA
K123345 · Rayence Co., Ltd. · Mar 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA
K122928 · Rayence Co., Ltd. · Jan 2013
DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA
K122919 · Rayence Co., Ltd. · Jan 2013
RADREX-I, SW V4.00 MODEL DRAD-3000E
K122842 · Toshiba America Medical Systems, In.C · Oct 2012
FDR GO FLEX
K120629 · Fujifilm Medical System U.S.A., Inc. · Aug 2012
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
K122182 · Rayence Co., Ltd. · Aug 2012