FDA 510(k) Application Details - K232298

Device Classification Name

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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
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Contact Shigeo Watanabe
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Regulation Number

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Classification Product Code OWB
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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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