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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K221144
Device Name PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
Applicant
Radisen Co., Ltd.
14f, 128, Gongduk B/D, 11, Saechang-Ro, Mapo-Gu
Seoul,  KR 04168
Applicant Contact John Lim
Correspondent
Mtechgroup
7505 Fannin St.
Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/20/2022
Decision Date 05/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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