Cleared Traditional

WERAY

K241963 · Picopack Co., Ltd. · Radiology

Jul 2024

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K241963 is an FDA 510(k) clearance for the WERAY, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Picopack Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on July 30, 2024, 27 days after receiving the submission on July 3, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K241963 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2024
Decision Date	July 30, 2024
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF