Cleared Special

K212753 - 0909FCB, 1212FCA
(FDA 510(k) Clearance)

K212753 · Rayence Co., Ltd. · Radiology

Oct 2021

Decision

48d

Days

Class 2

Risk

K212753 is an FDA 510(k) clearance for the 0909FCB, 1212FCA, 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 October 18, 2021, 48 days after receiving the submission on August 31, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K212753 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 31, 2021
Decision Date	October 18, 2021
Days to Decision	48 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF