Cleared Special

1717FCC

K210985 · Rayence Co., Ltd. · Radiology
Apr 2021
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K210985 is an FDA 510(k) clearance for the 1717FCC, 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 April 28, 2021, 27 days after receiving the submission on April 1, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K210985 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2021
Decision Date April 28, 2021
Days to Decision 27 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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