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FDA 510(k) Application Details - K232298
Device Classification Name
More FDA Info for this Device
510(K) Number
K232298
Device Name
DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
Applicant
Canon Inc.
9-1 Imaikami-cho, Nakahara-ku
Kawasaki 211-8501 JP
Other 510(k) Applications for this Company
Contact
Shigeo Watanabe
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/01/2023
Decision Date
04/26/2024
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
FDA Source Information for K232298
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