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FDA 510(k) Application Details - K212051
Device Classification Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
More FDA Info for this Device
510(K) Number
K212051
Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant
ASTEL Inc.
26-79, Gajeongbuk-ro, Yuseong-gu
Daejeon 34113 KR
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Contact
Yonghwan Jeon
Other 510(k) Applications for this Contact
Regulation Number
892.1650
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Classification Product Code
MQB
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More FDA Info for this Product Code
Date Received
06/30/2021
Decision Date
08/25/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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