Cleared Special

K171420 - 1717SCC_127um and 1717SCC_140um

K171420 is the FDA 510(k) clearance for 1717SCC_127um and 1717SCC_140um by Rayence Co., Ltd.. It is a Class 2 Radiology device (product code MQB) cleared through the Special 510(k) pathway after a 25-day FDA review.

K171420 · Rayence Co., Ltd. · Radiology device
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Jun 2017
Decision
25d
Days
Class 2
Risk

K171420 is an FDA 510(k) clearance for the 1717SCC_127um and 1717SCC_140um. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Rayence Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on June 9, 2017 after a review of 25 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 K171420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2017
Decision Date June 09, 2017
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
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 Consultant

Mtechgroup
Dave Kim

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K171420.
1417WGC_127um and 1417WGC_140um
K171417 · Rayence Co., Ltd. · Jun 2017
1417WCC_127um and1417WCC_140um
K171418 · Rayence Co., Ltd. · Jun 2017
1717SGC_127um and 1717SGC_140um
K171419 · Rayence Co., Ltd. · Jun 2017
DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
K170332 · Canon, Inc. · Mar 2017
1012WCC, 1012WGC
K162518 · Rayence Co., Ltd. · Oct 2016
1717WCC / 1717WGC
K162519 · Rayence Co., Ltd. · Oct 2016