Cleared Traditional

1717SGN / 1717SCN Digital Flat Panel X-ray Detector

K150150 · Rayence Co., Ltd. · Radiology
Mar 2015
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K150150 is an FDA 510(k) clearance for the 1717SGN / 1717SCN Digital Flat Panel X-ray Detector, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Rayence Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on March 27, 2015, 63 days after receiving the submission on January 23, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K150150 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2015
Decision Date March 27, 2015
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

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

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