Cleared Traditional

Rextar Pro

K242185 · Raypia Co., Ltd. · Radiology

Dec 2024

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K242185 is an FDA 510(k) clearance for the Rextar Pro, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Raypia Co., Ltd. (Gangseo-Gu, Seoul, KR). The FDA issued a Cleared decision on December 4, 2024, 132 days after receiving the submission on July 25, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K242185 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2024
Decision Date	December 04, 2024
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF