Cleared Special

EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i

K151707 · Rayence Co., Ltd. · Radiology
Jul 2015
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K151707 is an FDA 510(k) clearance for the EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Rayence Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on July 19, 2015, 25 days after receiving the submission on June 24, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K151707 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2015
Decision Date July 19, 2015
Days to Decision 25 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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