Cleared Special

0909FCC, 0909FCC-HS

K240371 · Rayence Co., Ltd. · Radiology
Mar 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K240371 is an FDA 510(k) clearance for the 0909FCC, 0909FCC-HS, 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 7, 2024, 29 days after receiving the submission on February 7, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K240371 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2024
Decision Date March 07, 2024
Days to Decision 29 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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