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FDA 510(k) Application Details - K221144
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K221144
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
Radisen Co., Ltd
14F, 128, Gongduk B/D, 11, Saechang-ro, Mapo-gu
Seoul 04168 KR
Other 510(k) Applications for this Company
Contact
John Lim
Other 510(k) Applications for this Contact
Regulation Number
892.1650
More FDA Info for this Regulation Number
Classification Product Code
MQB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/20/2022
Decision Date
05/13/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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