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FDA 510(k) Applications Submitted by JOHN LIM
FDA 510(k) Number
Submission Date
Device Name
Applicant
K151014
04/16/2015
Aura DR 43C-AG flat panel detector
ABYZR CO., LTD
K180989
04/16/2018
PEDRA-17F Digital Flat Panel X-ray Detector
Radisen Inc.
K221144
04/20/2022
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
Radisen Co., Ltd
K213520
11/03/2021
AXIR-CX
Radisen Co., Ltd
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