Cleared Special

1717SCV, 1717SGV

K201796 · Rayence Co., Ltd. · Radiology
Jul 2020
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K201796 is an FDA 510(k) clearance for the 1717SCV, 1717SGV, 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 July 23, 2020, 23 days after receiving the submission on June 30, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K201796 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2020
Decision Date July 23, 2020
Days to Decision 23 days
Submission Type Special
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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